Maquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
Maquet Critical Care AB is recalling nine Y Sensor Modules for the SERVO-U/-N ventilator systems because they did not undergo required electrical safety and functional tests during production.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to undergo required electrical safety and functional tests, creating a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Maquet Critical Care AB, a subsidiary of Getinge, is recalling nine units of the GETINGE Y SENSOR Module (Model Number 6693662) used in the SERVO-U and SERVO-N continuous ventilator systems. The recall was initiated because the modules did not undergo electrical safety tests and functional tests during production.
The affected units were distributed nationwide in the United States, specifically in the states of California, Georgia, Minnesota, and New York. The specific serial numbers for the recalled units are 21049, 21088, 21089, 21093, 21100, 21103, 21108, 21114, and 21115. The Device Unique Identifier (DUI/DI) is 07325710000304.
Healthcare facilities should check their inventory for these specific serial numbers and stop using the affected modules. Users should contact Maquet Critical Care AB for further instructions on how to proceed with the recall.
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.
- Manufacturer
- Maquet Critical Care AB
- Affected units
- 9
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 (9)
- DUI/DI 07325710000304
- Serial/Lot Numbers: 21049
- 21088
- 21089
- 21093
- 21100
- 21103 21108
- 21114
- 21115.
Distribution
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