Getinge Disinfection Ab recalled 788 units of the 88-Series Washer-Disinfector worldwide, including US states Colorado, Massachusetts, New Mexico and New Hampshire. The device can overheat if circulation pressure calibration is not performed or performed incorrectly and the low-pressure alarm fails to trigger. Manufacturers advise stopping use and following recall instructions.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Getinge Disinfection Ab or your healthcare provider for instructions. Notification method: Letter
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This device is a medical washer-disinfector used in healthcare facilities to clean and disinfect instruments.
Overheating during operation can lead to device malfunction or safety concerns if calibration is incorrect and the low-pressure alarm fails.
This recall is not described as part of a broader industry pattern in the provided information.
Immediate cessation of use and adherence to recall instructions to protect patients and staff.
Manufacturer recall notice; FDA enforcement page Z-0016-2026; unit labeling on the device
Refunds or replacements not specified in the notice; follow manufacturer instructions; expect processing timelines per hospital procurement processes
Keep recall notification, serial numbers, calibration records, and communications with Getinge
Model Number: 88-5. UDI-DI 07340153700109 and 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating. Distribution: Worldwide, including US states listed and numerous countries. Recall Date: 2025-08-29. Status: ACTIVE.
No specific injuries or incidents are disclosed in the provided recall notice.
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