| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00904-1 |
| Product Name/Description |
Maquet Heater-Cooler Unit HCU 40
All Serial Numbers below 90441000
ARTG Number 144010 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Maquet Cardiopulmonary has developed and validated new and revised cleaning and disinfection procedure for HCU 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all HCU 40 systems in the field.
This update also includes the following actions:
1. Replacement of Valves:
Existing valves will be replaced by successors with proven material compatibility with the new cleaning and disinfection procedure;
2. Replacement of Flow Sensors:
In HCU 40 devices with serial number below 90440266 the mechanical flow sensor will also be replaced by its successor to ensure material compatibility with the new cleaning and disinfection procedure; and
3. Software Update Release 1.2.3.0:
HCU 40 devices will be updated with the new software (release 1.2.3.0) including a new cleaning wizard guiding the user through the new cleaning and disinfection process step by step. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Actions to be taken by users:
1. The update on HCU 40 systems has to be performed by authorised Maquet service personnel according to the Update Instruction as soon as possible;
2. Fill out the supplied Acknowledgement Form and return it as soon as possible to your local Maquet representative;
3. Incorporate the new cleaning and disinfection procedures into operating processes, and conduct any necessary training;
4. Continue to monitor the hygiene (contamination levels) in accordance with internal practices; and
5. Immediately report any contamination findings to the local Maquet representative by filing a complaint.
This action has been closed out on the 29/11/2018. |
| Contact Information |
1800 605 824 - Getinge Customer Service |