Getinge Model 88-5 Washer-Disinfector Recalled for Overheat Risk
Getinge 88-Series Washer-Disinfector Model 88-5 units may overheat if the circulation pressure calibration was not performed correctly and the low-pressure alarm fails to trigger. 902 units are affected worldwide.
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: FDA Class II device recall involving overheat hazard with potential for burn injury. No illnesses or injuries have been reported, making this a risk-of-harm scenario where injury has not yet been reported, consistent with the High severity criterion.
Plain-English summary
Getinge 88-Series Washer-Disinfector Model 88-5 units are subject to this recall. This medical device is designed for sterilization and disinfection of medical instruments. A total of 902 units have been identified as affected.
The device poses a potential overheat risk during operation if the circulation pressure calibration was not performed or was performed incorrectly, and the low-pressure alarm does not trigger properly. Overheating could result in burn injuries to users or staff.
The affected devices have been distributed worldwide, including the United States (Colorado, Massachusetts, New Mexico, and New Hampshire) and many countries including Canada, Australia, United Kingdom, Japan, China, and others. The impacted units are Model Number 88-5 with UDI-DI Numbers 07340153700109 or 07340153700116, and Software Version GD 14080 Rev A.
Healthcare facilities and operators with this device should contact Getinge Disinfection Ab to verify their device status. Device use should be discontinued until circulation pressure calibration is verified and the low-pressure alarm function is confirmed to be working properly.
The recalled product
- Product
- Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
- Manufacturer
- Getinge Disinfection Ab
- Hazard
- overheat
- burn-injury
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 (1)
- Model Number: 88-5. UDI-DI Numbers: 07340153700109
Distribution
Distributed nationwide across the United States.
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