Events

Rappel de Device Recall Parks Medical Ultrasonic Doppler Flow Detector

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Parks Medical Electronics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    45800
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0670-2008
  • Date de mise en oeuvre de l'événement
    2007-11-08
  • Date de publication de l'événement
    2008-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66175
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Ultrasonic Doppler Flow Detector - Product Code DPW
  • Cause
    Premature battery failure: wrong acid flux used on circuit board which may lead to premature battery failure of ultrasonic non-directional doppler flowmeter.
  • Action
    811-B: On 9/28/07 Parks Medical Electronics notified their related U.S. distributor, Parks Medical Electronics Sales, Inc., Las Vegas, NV by email instructing them to stop further shipments. On 10/1/07 firm followed up with phone call instructing all units be returned for rework. On 11/8/07 firm sent replacement units accompanied with a Warranty Exchange Letter to their other U.S. customers notifying them of affected units. Letters were customized for each customer with a fill-in-the-blank of the model and serial numbers. Letters and replacement units were sent UPS 2nd Day Air and informed customer about the assembly error and instructions for returning the defective units. On 11/8/07 emails were sent to Brazilian and Australian distributors informing about assembly error and affected units. Rework instructions and a schematic were provided by email for each distributor to perform their own rework. On 11/28/97 Canadian customers were sent Warranty Exchange Letters and replacement units via UPS Ground. Firm is retrieving units from US and Canadian firms and will rework them. Firm is waiting to hear whether Brazilian or Austraian distributors need to sub-recall. Canadian distributors instructed to conduct subrecall if needed. All returned units will be reworked by disassembly of unit, removal of affected printed circuit board, washing board to remove acid flux, and testing.

Device

Device Recall Parks Medical Ultrasonic Doppler Flow Detector
  • Modèle / numéro de série
    Model 811-B Serial Numbers: 811B-600001876, 811B-600001877, 811B-600001878, 811B-600001879, 811B-600001880, 811B-600001882, 811B-600001883, 811B-600001884 (distributed to Australia); 811B-600001774, 811B-600001775, 811B-600001776, 811B-600001881, 811B-600002008, 811B-600002009, 811B-600002044 (distributed to Canada); 811B-600001762, 811B-600001763, 811B-600001764, 811B-600001765, 811B-600001766, 811B-600001767, 811B-600001768, 811B-600001769, 811B-600001770, 811B-600001771, 811B-600001772, 811B-600001773, 811B-600001777, 811B-600001793, 811B-600001794, 811B-600001795, 811B-600001796, 811B-600001797, 811B-600001798, 811B-600001799, 811B-600001803, 811B-600001804, 811B-600001818, 811B-600001819, 811B-600001820, 811B-600001821, 811B-600001822, 811B-600001823, 811B-600001824, 811B-600001825, 811B-600001826, 811B-600001852, 811B-600001853, 811B-600001854, 811B-600001855, 811B-600001856, 811B-600001857, 811B-600001858, 811B-600001859, 811B-600001860, 811B-600001861, 811B-600001862, 811B-600001863, 811B-600001864, 811B-600001865, 811B-600001866, 811B-600001867, 811B-600001868, 811B-600001870, 811B-600001886, 811B-600001888, 811B-600001889, 811B-600001896, 811B-600001897, 811B-600001898, 811B-600001899, 811B-600001900, 811B-600001901, 811B-600001910, 811B-600001911, 811B-600001912, 811B-600001926, 811B-600001930, 811B-600001955, 811B-600001956, 811B-600001959, 811B-600001960, 811B-600001961, 811B-600001962, 811B-600001974, 811B-600001975, 811B-600001976,  811B-600001981, 811B-600001997, 811B-600001998, 811B-600002005, 811B-600002006, 811B-600002007, 811B-600002010, 811B-600002011, 811B-600002012, 811B-600002013, 811B-600002014, 811B-600002015, 811B-600002016, 811B-600002017, 811B-600002018, 811B-600002019, 811B-600002022, 811B-600002023, 811B-600002024, 811B-600002025, 811B-600002026, 811B-600002027, 811B-600002028, 811B-600002029, 811B-600002030, 811B-600002031, 811B-600002036, 811B-600002037, 811B-600002038, 811B-600002039, 811B-600002040, 811B-600002041, 811B-600002042, 811B-600002043, 811B-600002044 (distributed in US)   Code Breakdown Example: 811B-600001896; 811B = the series; 6 = the version; 00 = the revision; 001896 = the unique identifier number.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, Brazil, Australia, and Canada
  • Description du dispositif
    Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
  • Manufacturer
    Parks Medical Electronics Inc

Manufacturer

Parks Medical Electronics Inc
  • Adresse du fabricant
    Parks Medical Electronics Inc, 19460 Sw Shaw St, Aloha OR 97007-1242
  • Société-mère du fabricant (2017)
    Parks Medical Electronics Inc
  • Source
    USFDA