Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Medtronic, inc. has initiated a review of the mosaic aortic abturator (model 7305), due to the higher-than-expected transvalvular gradients occurring after implantation.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The company radiometer medical aps has learned that the outer shell of some membranes for analyzers of blood gases of the abl 800 flex series can contain enzymes, which leads to inaccuracy in the indication of results. in case of questions from users, they can contact the distributor.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
According to the certificate of expertise dated april 20, 2016, ojsc thermopribor, the main distinguishing features of the original thermometer from the counterfeit one are: 1. thermometer scale: marking on the scale of the counterfeit thermometer is printed in a larger font than in the original thermometer. on all scales of thermometers produced by odo “thermopribor” on the reverse side of the top there is a scale number. on counterfeit products - no digital scale. 2. verification mark: the mark of a counterfeit thermometer is distinguished by its type and size. the stamp of a counterfeit thermometer is applied in another way, the glass at the site of application of the stamp to the touch has a rough surface, on the original thermometers - smooth. the image of the stamp has clear boundaries, on the original "blurry". 3. case: in the original thermometer - semicircular, in counterfeit - square. a color copy of the examination certificate dated april 20, 2016 of ojsc “termopribor” is on the website of the ue “center for expertise and testing in health care” www.Rceth.By in the section “safety and quality of medical products” http://www.Rceth.By/ com / safety / medsafety. in connection with the above, in accordance with clause 8.16 of the statute on the ministry of health of the republic of belarus, approved by decree of the council of ministers of the republic of belarus of 28.10.2011 no. 1446 (as amended on 27.12.2012) “on some issues of the ministry of health and measures to implement the decree of the president of the republic of belarus dated august 11, 2011 no. 360 »the ministry of health of the republic of belarus exercises state control over the quality of medical devices and medical equipment when health facilities are available pharmacy network, business entities of non-state ownership of counterfeit products: medical thermometer maximum glass mercury (coated / uncoated) tu 944-033-402-2008, produced by termopribor klin, russia, these medical products must be returned to the supplier product and inform the ue "center for expertise and testing in health care", at: friendly 2a, minsk, 220037.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Accumetrics withdraws the verifynow iib / iiia test (serial numbers: wc0182b, wc0182c, wc0182a, a, a0101d, wc0182e, wc0182f, wc0182g, wc0180c, wc0180e, wc0180f, wc0181a, wc0181c, wc0181d, wc0181f, wc0180a, wc0180f, wc0181a, wc0181c, wc0181c, wc0181f, wc0180a, wc0180f, wc0181a, wc0181e, wc0181c wc0181g, wc0181h, wc0181j, wc0181k) due to the fact that this may lead to erroneous results with low levels of platelet aggregation (pau). accumetrics sent letters with information about what actions need to be taken in this situation.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Becton dickinson and company has identified a malfunctioning component of diagnostic medical equipment, which can lead to false results in clinical specimens.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
In rare cases, the software of the d-10 system may produce an additional result, duplicating the result of the comparison of the previous and next samples. the duplicate is easily detected when sorting the identification numbers of the samples examined during the day, in this case the serial numbers of the samples are duplicated. the manufacturer recommends that users carefully study the reports or printed chromatograms obtained during the day, in order to identify duplicates. such duplication may lead to inconsistent sampling results.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The manufacturer initiated the recall of one batch of products (2013040058) due to the lack of tightness of the catheter's packaging, which may violate the sterility of the product. consumers are encouraged to return the withdrawn products.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The manufacturer found that when using several isocenters (several radiation therapy goals) within one manipulation, the exactrac patient positioning and verification system with the exactrac v6.0.3 software version can position the patient in the wrong isocenter position. brainlab asks end users to avoid using multiple isocenters during treatment. if treatment with several isocenters cannot be avoided, it is necessary to close the exactrac program after treatment of the patient using one isocenter and restart the treatment plan before choosing the next isocentre. to solve this problem, brainlab is planning to release a software update.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
During the observation of the equipment during the post-marketing period, the manufacturer found that the components of the system during operation could in rare cases cause blocking of the magnetic brakes or a restart of the freezing system, which can increase the time of the surgical intervention.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Clarity medical systems, inc. recently identified the incorrect operation of the three software versions (version 6.0, 6.1 and 6.2). under certain conditions, the display may show the calculated value of the patient's age, which is 2 weeks less than the actual age. this miscalculation occurs at regular intervals, does not affect the date of birth entered, and has no effect on any other functions of the retcam system. what to do: 1. do not rely on the calculated age of the patient with the retcam system. 2. use the entered date of birth. 3. any medical decisions (for example, screening dates) that were based on the age calculated by the retcam system should be revised. currently, the company is developing a software solution to eliminate the identified deficiency, the results will be announced later.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Product labeling contains an incorrect serial number resulting from duplicating a serial number. the manufacturer has sent a notification to all users, in which it identifies: the product, the problem and the subsequent actions of the users.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Abbott decided to report the recall of the architect total t3 reagent kit (lot: 38901ui00, 38901ui01), and provide instructions on the actions that should be taken. the company has determined that 17% of the reagents of the two lots listed above may show lower relative light units (rlu) than expected, which in turn may affect the results of patient analyzes and make the indicators higher than expected. if you use or have reagent kits from lots 38901ui00 or 38901ui01, you should: stop using and destroy all remaining reagent kits according to your laboratory procedures; review previously obtained patient test results.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
As part of the supervisory activities of drager medical gmbh, it became known that when using an additional ps500 power supply unit when connected to evita infinity v500 and babylog vn500 ventilators, the battery capacity holds the charge not as long as expected, although the battery indicator shows a fairly charged battery. in this case, the indicators (alarms) "low battery" (battery low) and "power source discharged" (battery depleted) do not always work when the battery level is below 10%. to ensure the normal operation of the devices, it is necessary to contact the representative of drager and organize the exchange of the battery as a temporary solution. before exchanging the battery, drager recommends: 1. use an additional power supply to transport the patient only if absolutely necessary. 2. do not rely on the battery status indicator. 3. always monitor the patient and the ventilator during transport. ensure that there is a breathing bag for manual ventilation, as indicated in the manual for ventilators. 4. if the power supply is discharged during transportation, it is necessary to provide manual ventilation of the lungs and immediately connect the ventilator to the wall-mounted power supply to resume ventilation of the lungs.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Edwards lifesciences llc, united states of america.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The manufacturer has determined that the innova system may not boot after turning on the power or after rebooting the system. also, the system can arbitrarily shut down during research, which can lead to a complete loss of interventional visualization in real time. the loss of visualization capability during fluorography can cause significant harm to the patient, if coronary intervention occurs during the "sensitive phase".
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The manufacturer, on its own initiative, decided to implement a voluntary global recall from the medical device market. the reason for the global recall from the market was the analysis of unpublished data, carried out at the request of the ethicon medical safety team by two independent registries in the field of hernia treatment (the german herniamed registry and the danish hernia database dhdb). the rate of relapses / reoperations after laparoscopic surgery to remove ventral hernias using medical devices was higher than the average recurrence rate among patients in these registers.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
In connection with the incorrect labeling of the product, the manufacturer sent letters to all consumers about the events to be carried out when using the specified batch of high-pressure syringes everest 20 atm. (batch number 50755851), and the need to contact your medtronic distributor. the number of sold products was 191 pcs. according to the data in the letter to medtronic, the products were sold in the united states in 6 states: texas, maine, iowa, pennsylvania, oregon and new hampshire.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
The manufacturer has determined that there is a potential problem with the device running software version vc21b (serial numbers 10094135, 10094137, 10094141, 10280959) in combination with a large display, under certain circumstances, radiation radiation may be blocked. the manufacturer began work on changing the software and sent a notice to all users, identifying: the product, the problem and the subsequent actions of the users. in case of problems, it is recommended that everyone contact the local representatives of the manufacturer.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Siemens ag detected a defect in the operation of the software of the tomograph somatom definition as, due to a malfunction in the system, the display may hang during the interventional procedures.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Siemens healthcare diagnostics carries out corrective actions for the advia centaur xp analyzer and reports the following. when the analyzer's cover is lifted, the cover is supported by a gas spring (smn 10321635) attached to the middle of the cover. over time, the gas spring may lose its effectiveness and not keep the cover in full or partially open position. this may cause the cover to fall during equipment maintenance. thus, the cover can cause injury to the operator if dropped. this fact does not affect the results of research.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Due to the increasing number of consumer complaints that the immulite analyzer produces false-positive results of thyroid hormone in healthy people when using reagent t3 free from some batches, the manufacturer recommends not to use certain batches of these reagents and contact your regional distributor.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
This letter was initiated in order to inform you of the upcoming safety check of a symbia s or symbia t emission scanner. this check is necessary due to the fact that siemens medical solutions usa, inc. received reports of unintended radial movement of the detectors, which could cause injury to the patient. if symbia s or t scanners detect such errors, they are automatically disabled. if your tomograph with the message "the system requires service. please contact your service representative" has been turned off, it will remain off until the fault has been manually fixed by the service.
Belarussian data is current through June 2016. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Belarus.
Notes supplémentaires dans les données
Cause
Volcano corporation has initiated a voluntary recall of all lots of the device for pulling a single-use catheter trackback ii: code 91003. the trackback ii is intended for use with eagle eye® intravascular imaging catheters. the device provides stable and accurate movement of the catheter, which allows you to evenly collect image data. the recall is initiated by the company as a precautionary measure due to concerns about the integrity of the primary packaging, which may affect the sterility of the product after shipment. volcano corporation has not received any complaints about this and no reports of harm to the patient or his death caused by the use of the product. however, the company asks to immediately stop using the device in trackback ii and return unused devices to the distributor.