Recall Z-1721-2025 ยท MEC Disinfector, Medical Devices
Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56M
| Date | May 5, 2025 (initiated Apr 2, 2025) |
| Status | Open, Classified |
| Reason | The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing. |
| Root cause | Under Investigation by firm |
| Action | On April 2, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions 1. Check the serial number of yourWasher Disinfector Aquadis 56 to determine if it is affected. The serial number can be found on the marking label, located on the inside of the front Panel door. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Complete and return the enclosed response form Getinge by e-mailing a copy to recallresponses.qrc@getinge.com. Note: If y |
| Quantity | 424 units (79 US, 345 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Brazil, Canada, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.