Device product
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Z-1823-2025
Product summary
- Event
- Event 96820
- Status
- Ongoing
- Classification
- Class II
- Quantity
- US: 2 units; OUS: 168 units
- Official record key
device-enforcement:Z-1823-2025
Official wording
Reason: HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Code information: Model No. 701045366; UDI 04037691456584; All Serial No.
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.
Derived failure modes
-
Unknown
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.