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
Reported: August 31, 2022 Initiated: July 20, 2022 #Z-1560-2022
Product Description
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
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.
Details
- Recalling Firm
- Getinge Usa Sales Inc
- Units Affected
- 37000 (11089 US)
- Distribution
- 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.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Getinge Usa Sales Inc. Units affected: 37000 (11089 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Critical. Recall number: Z-1560-2022.
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