Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Recall Initiated
- April 30, 2025
- Posted
- May 27, 2025
- Recall Number
- Z-1823-2025
- Quantity
- US: 2 units; OUS: 168 units
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.
Lot / Code Info
Model No. 701045366; UDI 04037691456584; All Serial No.
Root Cause
Under Investigation by firm
Action Taken
An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated April 2025 was mailed to consignees. The notification instructs consignees to identify and quarantine all affected product. Consignees should forward the provided recall notification to any individuals within their organization that utilize the affected device or to the entity it was distributed to. Consignees should complete and return the provided response form by email to recallresponses.qrc@getinge.com. Getinge Customer Service can be contacted at 888-943-8872 option 2 or by email at ACTSalesSupport.US@getinge.com to coordinate return of affected devices.