Recall Z-2963-2026 ยท CBK Ventilator, Continuous, Facility Use
Maquet Critical Care AB
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous, facility use
| Date | Aug 14, 2026 (initiated Jun 30, 2026) |
| Status | Open, Classified |
| Reason | Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the SERVO-U/-N ventilator system, due to missing production safety electrical testing. |
| Root cause | Under Investigation by firm |
| Action | Getinge issued an URGENT MEDICAL DEVICE CORRECTION notice was issued to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk to health, and requested the following: "Prior to the replacement, Getinge requests that you take the following actions: 1. Ensure all affected product in your inventory has been identified. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Technical Service if you have questions at 888-943-887 |
| Quantity | 9 units |
| Distribution | US Nationwide distribution in the states of CA, GA, MN, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 Maquet Critical Care AB, Apr 20, 2021 |