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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
Related recalls
Same manufacturer · Getinge Usa Sales Inc
See all →- SevereSevoflurane Vaporizer Quik-Fil Recalled Due to Chemical Degradation Risk
FDA (Devices) · 2025-02-19
- HighOperating Table May Stop Unexpectedly During Surgery Due to Control Error
FDA (Devices) · 2024-11-20
- ModerateGetinge MEERA CL Mobile Operating Table Recalled for Intermittent Movement Errors
FDA (Devices) · 2024-11-20
- HighMEERA CL Mobile Operating Table Control Malfunction Recall
FDA (Devices) · 2024-11-20
- ModerateGetinge MEERA CL mobile operating table recalled for sporadic movement errors
FDA (Devices) · 2024-11-20
Same hazard · loss of ventilation
See all →- CriticalAtlan A350XL anesthesia workstations recalled after piston ventilator failures during use
FDA (Devices) · 2025-10-08
- CriticalAtlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported
FDA (Devices) · 2025-10-08
- SeverePhilips Garbin EVO Ventilator False Battery Alarm Causes Ventilation Loss
FDA (Devices) · 2024-04-24
- SeverePhilips Trilogy Evo Ventilator Recall: Potential Loss of Ventilation Due to False Alarm
FDA (Devices) · 2024-04-24
- SeverePhilips Trilogy EV300 Ventilator False Power Alarm Defect Recall
FDA (Devices) · 2024-04-24
Similar recalls
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- SevereMaquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time
FDA (Devices) · 2013-05-08
- HighServo-air Ventilator Systems Lack Required Stability Warning Markings
FDA (Devices) · 2022-08-31
- SevereServo-u MR Ventilator System inaccurate patient circuit compliance measurement
FDA (Devices) · 2025-07-09
- SevereGetinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation
FDA (Devices) · 2023-02-01
- SevereGetinge Flow-c Anesthesia System Software Bug May Prevent Ventilation
FDA (Devices) · 2023-02-01