Getinge SERVO Y sensor module recalled over missing safety tests
Getinge's Maquet Critical Care AB recalled nine Y Sensor modules (Model 6693662) for SERVO-U and SERVO-N ventilator systems. The modules did not complete electrical safety and functional tests during production. They were distributed to facilities in California, Georgia, Minnesota, and New York, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Maquet recalls
What to do
- Check whether your facility uses a SERVO-U or SERVO-N ventilator with a Y Sensor module, Model 6693662.
- Compare the module's serial number to the recalled list: 21049, 21088, 21089, 21093, 21100, 21103, 21108, 21114, 21115.
- If your module is on the list, contact Getinge or Maquet Critical Care AB for instructions on next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
- Sold in
- Nationwide
- Made for
- All ages
Details
- Units affected
- 9 units
- Illnesses reported
- None reported
- Manufactured in
- Rontgenvagen 2, Solna, Sweden
- Classification
- Class II
- Recall number
- Z-2963-2026
In the FDA's words
- Description
- GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge. The module did not undergo electrical safety tests and functional tests during production. DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115. Distribution: US Nationwide distribution in the states of CA, GA, MN, NY. Affected quantity: 9 units
- Hazard
- The module did not undergo electrical safety tests and functional tests during production.