Getinge Servo ventilator systems recalled for loss of ventilation
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4. The recalled ventilator systems may fail to deliver ventilation, potentially resulting in hypoventilation, desaturation, hypoxemia, hypoxic injury, and circulatory failure in critical care patients.
Plain-English summary
Getinge Usa Sales Inc. is recalling Maquet Critical Care AB/Getinge Servo ventilator systems, including the Servo-u, Servo-n, Servo-u MR, and Servo-air models. The recall affects approximately 37,000 units worldwide, including 11,089 units in the United States.
The ventilator systems may generate a combination of alarms that interfere with normal operation, including loss of communication between the device and clinical staff and triggering of technical alarms. Most critically, the device may stop delivering ventilation entirely.
If a Servo ventilator system stops ventilating, patients may experience reduced breathing and oxygen deprivation, leading to hypoxemia (inadequate blood oxygen) and hypoxic injury (tissue damage from lack of oxygen). In severe cases, this may result in circulatory failure.
The recalled product
- Product
- 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
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- loss-of-ventilation
- device-malfunction
- hypoxemia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: Servo-air: 73257100031183 Servo-u
- Servo-n
Distribution
Distributed nationwide across the United States.
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