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U.S. Department of Health and Human Services

Class 2 Device Recall HKH 8820 Wall Holder

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 Class 2 Device Recall HKH 8820 Wall Holdersee related information
Date Initiated by FirmApril 30, 2025
Date PostedMay 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1823-2025
Recall Event ID 96820
510(K)NumberK102726 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductCardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Code Information Model No. 701045366; UDI 04037691456584; All Serial No.
Recalling Firm/
Manufacturer		 Maquet Cardiopulmonary Ag
Kehler Str. 31
Rastatt Germany
Manufacturer Reason
for Recall		HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 in CommerceUS: 2 units; OUS: 168 units
DistributionDomestic: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DTQ
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