Washer disinfectors recalled over overheating risk from incorrect pressure calibration
Getinge is recalling 902 88-Series washer-disinfectors that can overheat during operation if the circulation pressure calibration was not performed, or was performed incorrectly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Scored 3 under the risk-of-harm criterion: an overheating device with a non-triggering alarm poses a hazard and the record reports no injuries.
Plain-English summary
Getinge 88-Series Washer-Disinfectors, model number 88-5, are being recalled because the device can overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
The recall covers 902 units carrying UDI-DIs 07340153700109 and 07340153700116, running software version GD 14080 Rev A. Distribution was worldwide, including in Colorado, Massachusetts, New Mexico and New Hampshire in the United States. The FDA has classified the action as Class II.
The enforcement record describes the overheating potential and does not report injuries. Sterile processing departments operating affected units should follow Getinge's instructions for verifying the circulation pressure calibration.
The recalled product
- Product
- Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
- Manufacturer
- Getinge Disinfection Ab
- Affected units
- 902
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
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