| TGA Action ID |
RC-2026-RN-00377-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Getinge 88-5 Washer disinfector (all units with electrical heating)
Multiple Lot Numbers |
| ARTG Number |
409106 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The Getinge 88-5 washer disinfector heating element may overheat, caused by absent or incorrect calibration of the circulation pressure sensor.
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 (RC-2025-RN-00727-1) 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 occurred:
· The water circulation pressure is too low in combination with:
· The circulation pressure calibration not being performed or performed incorrectly and/or
· The low circulation pressure alarm is not triggered due to the alarm limit being changed by a technician.
This can result in the melting of insulation, cables, and hoses, and in some cases, may lead to smoke emission or fire. |
| Instructions for Customers/Users |
Getinge service technicians will be proactively reaching out to users to ensure the device is working appropriately. In this check the Getinge service technician will perform:
• A verification that the alarm limit for low pressure in the circulation system does not deviate from the factory settings of 20 kPa and correct it if any deviation is found.
• A calibration of the pressure sensor according to the updated procedure in the Service Manual. The method for calibration is revised and improved and will include the entire measurement chain, including the actual pressure sensor.
Updates are also being made to the Service Manual and PM Checklist
This action has been closed out on 21/08/2026 |
| Action Commencement Date |
22/05/2026 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 - Getinge Customer Service |