FDA recall Z-1823-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2025-04-30

Report date

2025-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rastatt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2025