Getinge 88-5 Washer Disinfector

Getinge 88-5 Washer disinfector machines are being recalled because their instructions for use need to be updated. This recall affects hospital, pharmacy, and laboratory facilities in New Zealand that use this equipment. The FDA has classified this as a Class I recall.

Recalling firm
Getinge Australia Pty Ltd (NZ)
Product
Getinge 88-5 Washer disinfector. [Device]. Model: Getinge 88-5 Washer disinfector (all units with electrical. Affected: Serial nubers - WAA060034, WAA068106, W50038320, W50046233
Reason
The initial investigation determined that the device was found to overheat during operation if the calibration of the circulation pressure was not performed or had been performed incorrectly and the alarm for low circulation pressure was not trigged., The information sent out in previous customer letter Medsafe Ref#35754 was a precautionary action that was taken by checking the Circulation Pressure value in Stand By mode, to verify it was 0.0 kPa or otherwise re-calibrate., Further investigation determined that the device could overheat during operation if the following conditions...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-05-26
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/eb8f36e0-6911-4ea8-a9f7-59db591687ea