FDA Medical Device Recalls (openFDA)
Maquet Cardiopulmonary Ag: Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Recall number
- Z-1823-2025
- Recalling firm
- Maquet Cardiopulmonary Ag
- Product
- Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
- Status
- Open, Classified
- Initiated
- 2025-04-30
- Posted
- 2025-05-27
- Terminated
- not on file
- Reason
- HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Model No. 701045366; UDI 04037691456584; All Serial No.
- 510(k) numbers
- ["K102726"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3009507273
- Firm city
- Rastatt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28