Maquet Cardiopulmonary Ag recalls Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHEL…

HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1823-2025
• FDA 510(k) clearance · K102726The device's official FDA premarket clearance record
• FDA device classification · DTQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Cardiopulmonary AgSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.