Z-1823-2025 Class II Ongoing
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.