FDA Medical Device Recalls (openFDA)
Maquet Medical Systems USA: Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
- Recall number
- Z-0290-2024
- Recalling firm
- Maquet Medical Systems USA
- Product
- Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
- Status
- Open, Classified
- Initiated
- 2023-10-12
- Posted
- 2023-11-09
- Terminated
- not on file
- Reason
- It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.
- Root cause
- Device Design
- Action
- An URGENT MEDICAL DEVICE Correction notification letter dated 10/12/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received a CARDIOHELP-i System having a serial number that is affected by this voluntary Medical Device Correction. " Please examine your inventory immediately to determine if you have any affected CARDIOHELP System(s) in your inventory. " Should you have any affected CARDIOHELP-i System(s), your unit(s) will need to be returned to Getinge for correction. Getinge will contact your facility to arrange the return of your unit for correction. A CARDIOHELP loaner can be provided if needed. " Please do not to fixate any accessory at the slide rail until the slide rail holders have been replaced. " Affected CARDIOHELP-i can be used for intra-hospital transport only when placed on a Sprinter cart. " Inter-hospital transport is not permitted until the slide rail holders have been replaced. " Please forward this information to all current and potential CARDIOHELP-i users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE- CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to Cardiohelpsliderail2023.act@getinge.com or by faxing the form to 1-866-313-4049. Type of Action by Getinge: A Getinge representative will contact you to arrange for the repair of your CARDIOHELP -i unit(s). Getinge will correct your CARDIOHELP -i unit(s) upon receipt and will return your unit(s) once correction has been completed. This voluntary correction only affects the products listed on Page 1; no other products are affected by this voluntary correction. We apologize for
- Quantity
- 1022 units
- Distribution
- US Nationwide.
- Lot, serial or model codes
- UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868
- 510(k) numbers
- ["K133598"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3008355164
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
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