Health product recall

Getinge Washer/Disinfector

Last updated

Summary

Product
Getinge Washer/Disinfector
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalogue number
Getinge Washer/Disinfector W50037316 88-5

Issue

The issue found can cause the device to overheat during operation if the circulation pressure calibration was not performed or been performed incorrect and the low-pressure alarm is not triggered. 

The scope of this action is the electrical heated 88-5 washer disinfectors.
Justification: the construction on steam heated devices is different and the heating elements cannot be overheated.

This field action is initiated to verify that the circulation pressure in standby mode reads 0.0 kPa. If the value deviates from 0.0 kPa, the device must be recalibrated by a qualified technician to ensure safe continued clinical use.

Recall start date: August 21, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Getinge Disinfection AB

Ljungadalsgatan 11, Vaxjo, Sweden, 35246

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-77997

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