Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
FDA Recall Z-1823-2025 · Posted 2025-05-27
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Recalling FirmMaquet Cardiopulmonary Ag
Recall StatusOpen, Classified
Product CodeDTQ
Date Initiated2025-04-30
Product QuantityUS: 2 units; OUS: 168 units
Reason for Recall
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
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 [email protected]. Getinge Customer Service can be contacted at 888-943-8872 option 2 or by email at [email protected] to coordinate return of affected devices.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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