Model Number: HT70 and HT70 Plus. Serial numbers: N12HT700514226 to N12HT700514231, N12HT700514233 to N12HT700514236, N12HT700514238 to N12HT700614280, N12HT700614282 to N12HT700614299, N12HT700614301 to N12HT700614309, N12HT720410266 to N12HT720410268, N12HT720410271, N12HT720410273, N12HT720410282, N12HT720410283, N12HT720410286, N12HT720410288, N12HT720410289, N12HT720410290, N12HT720410294 to N12HT720510300, N12HT720510302, N12HT720510322 to N12HT720510330, N12HT720510332 to N12HT720510344.
Worldwide distribution: USA (nationwide) and countries of: Brazil, Chile, Egypt, France, Hong Kong, India, Japan, Norway, Philippines and South Africa.
Description du dispositif
Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. || Product Usage: || The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
Description du dispositif
Breas Vivo 50 Home Care Ventilator || Product Usage: || Respiratory Care
All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens).
The Servo ventilators 300 (SV300) and 300A (SV300A) are intended for general and critical care ventilation of adult, paediatric and neonatal patients.
Affected ventilators are those with an automode function. Automode is a function where two consecutive breathing efforts from the patient will shift the ventilator status from control mode to a support mode. The ventilator will remain in the support mode as long as the patient keeps breathing; if the patient stops breathing the ventilator will shift back to the control mode.
The Servo-I ventilator is not affected by this issue.
Legendair and Supportair Portable Ventilators.
Specific ventilator codes (see FSN).
Supplied by Airox and Covidien.
These ventilators are designed primarily for use by patients at home.
The affected ventilator codes are as follows:
Legendair™ Single Branch
4095700
-
INTL LEGENDAIR SINGLE BRANCH
4095701 - GB NO LEGENDAIR SINGLE BRANCH
4095702 - DE LEGENDAIR SINGLE BRANCH
4095705 - CA LEGENDAIR SINGLE BRANCH
4095706 - JP LEGENDAIR SINGLE BRANCH
4095709 - DK LEGENDAIR SINGLE BRANCH
4095721 - AU LEGENDAIR SINGLE BRANCH
Legendair™ Double Branch
4095900 - INTL LEGENDAIR DOUBLE BRANCH
4095901 - GB NO LEGENDAIR DOUBLE BRANCH
4095902 - DE LEGENDAIR DOUBLE BRANCH
4095905 - CA LEGENDAIR DOUBLE BRANCH
4095906 - JP LEGENDAIR DOUBLE BRANCH
4095909 - DK LEGENDAIR DOUBLE BRANCH
4095921 - AU LEGENDAIR DOUBLE BRANCH
Supportair™
4096200 - INTL SUPPORTAIR
4096201 - GB SUPPORTAIR
4096202 - DE SUPPORTAIR
SLE 4000/5000 ventilator.
Power supply unit (PSU) model FP110-410.
Specific serial numbers.
Affected products can be identified as shown below:
Affected product
Ventilator model SLE 4000: Serial numbers 42040 and below
Ventilator model SLE 5000: Serial numbers 53164 and below
Power supply unit model FP110-410: Serial numbers from 163746 to 167558 inclusive
Other model FP110-410 PSUs outside the above serial range may be affected if they contain ‘tall’ capacitors. These can be checked by following the recommendations in the manufacturer’s
technical bulletin
.