Z-1823-2025 Class II Ongoing

Recalled by Maquet Cardiopulmonary Ag — Rastatt, N/A

Recall Details

Product Type
Devices
Report Date
June 4, 2025
Initiation Date
April 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
US: 2 units; OUS: 168 units

Product Description

Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.

Reason for Recall

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

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.

Code Information

Model No. 701045366; UDI 04037691456584; All Serial No.