Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Reported: June 4, 2025 Initiated: April 30, 2025 #Z-1823-2025
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.
Details
- Recalling Firm
- Maquet Cardiopulmonary Ag
- Units Affected
- US: 2 units; OUS: 168 units
- 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.
- Location
- Rastatt, N/A
Frequently Asked Questions
What product was recalled? ▼
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.. Recalled by Maquet Cardiopulmonary Ag. Units affected: US: 2 units; OUS: 168 units.
Why was this product recalled? ▼
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 4, 2025. Severity: Moderate. Recall number: Z-1823-2025.
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