Open, Classified

Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000

FDA Recall Z-1560-2022 · Posted None

Recall StatusOpen, Classified

Product CodeCBK

Date Initiated2022-07-20

Product Quantity37000 (11089 US)

Reason for Recall

Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device stops ventilating due to this issue, it may lead to hypoventilation and consequently desaturation, with patient outcomes including hypoxemia and hypoxic injury, which might result in circulatory failure.

Firm Action

On July 20, 2022, the firm sent Urgent Medical Device Correction letters to customers. Customers were instructed to examine their inventory immediately to see if they had any of the affected serial numbers on hand. Per the company, customers may continue to use their Ventilator System in accordance to the Users manual with extra attention to the following precautions as listed in chapter 1.2 Safety Guidelines of the User s manual: o The patient must never be left unattended when connected to the ventilator system o Always make sure that a manual resuscitator is readily available The firm has updated the software platform for Servo systems to version 4.4 which contains bug fixes to address the technical alarms. If you have any questions, please contact your Maquet Critical Care AB/Getinge representative or call the Maquet Critical Care AB/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Root Cause

Software in the Use Environment

Distribution Pattern

Worldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech Republic, Italy, Belgium, Estonia, Greece, Finland, Portugal, Netherlands, Romania, Austria, Slovakia, Lithuania, Ireland, Latvia, Norway, Sweden, Malaysia, China, Singapore, Taiwan, Iceland, Slovenia, Hungary, Bulgaria, Denmark, Croatia, United Kingdom, Russia, Hong Kong, United Arab Emirates, Canada, Switzerland, Australia, New Zealand, Serbia, Kenya, South Africa, Palestine, India, Colombia, Macau, Argentina, Mexico, Japan, Brazil, Israel, South Korea, Turkey, Peru, Ukraine, Thailand, Polynesia(French), Morocco, Saudi Arabia, Iran, Martinique (French), Costa Rica, Kuwait, Algeria, Saint Helena, Syria, Chile, Qatar, Fiji, Lebanon, Sri Lanka, Jordan, Oman, Pakistan, Ecuador, Botswana, Mozambique, Netherlands, Antilles, Bolivia, Andorra, Aruba, Faroe Islands, Egypt, Libya, Indonesia, Bahrain, Uruguay, Guadeloupe (French), Puerto Rico, Bosnia-Herzegovina, Paraguay, Nepal, Nicaragua, Vietnam, Tunisia, El Salvador, Tanzania, Papua New Guinea, Philippines, Nigeria, Myanmar, Dominican Republic, Cuba, Russian Federation, Honduras, Zimbabwe, Moldova, Republic of Bangladesh, Maldives, Angola Mauritius, Sudan, Turkmenistan, Panama, Rwanda, Brunei Darussalam, and Georgia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB · 2021-04-20 K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB · 2020-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.