Recall Z-1823-2025 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiopulmonary Ag
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
| Date | May 27, 2025 (initiated Apr 30, 2025) |
| Status | Open, Classified |
| Reason | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated April 2025 was mailed to consignees. The notification instructs consignees to identify and quarantine all affected product. Consignees should forward the provided recall notification to any individuals within their organization that utilize the affected device or to the entity it was distributed to. Consignees should complete and return the provided response form by email to recallresponses.qrc@getinge.com. Getinge Customer Service can be contacted at 888-943-8872 option 2 or by email at ACTSalesSupport.US@getinge.com to coordinate r |
| Quantity | US: 2 units; OUS: 168 units |
| Distribution | Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102726 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, Apr 4, 2011 |