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

Hazard

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

Details from the source

Reason for recall: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. 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, Saudi Arabia, Spain, Switzerland, Thailand. Quantity: US: 2 units; OUS: 168 units Lot/code info: Model No. 701045366; UDI 04037691456584; All Serial No.

UPC codes

04037691456584

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.