Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital tran
FDA device recall Z-1823-2025 · posted 2025-05-27 · Open, Classified
Recall details
- Recalling firm
- Maquet Cardiopulmonary Ag
- Reason for recall
- HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- Action taken
- 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 return of affected devices.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DTQ
- Quantity affected
- 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,
- Date initiated
- 2025-04-30
- Date posted
- 2025-05-27
- Location
- Rastatt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOHELP SYSTEM (K102726) | Maquet Cardiopulmonary, AG | 2011-04-04 |