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[Recalled] Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle. — HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the p… | FDA 20

recall fda device germany

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductCardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Brand / manufacturerMaquet Cardiopulmonary Ag
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1823-2025
Country of noticeGermany
Risk levelClass II
Hazard typerecall
Notice date30 April 2025
EAN / barcode701045366

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.

This Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Maquet Cardiopulmonary Ag

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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