| Date Initiated by Firm |
October 12, 2023 |
| Date Posted |
November 09, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0290-2024 |
| Recall Event ID |
93013 |
| 510(K)Number |
K133598
|
| Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
|
| Product |
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) |
| Code Information |
UDI-DI: 04058863074863;
Serial Numbers: 90414355 through 90414868 |
Recalling Firm/
Manufacturer |
Maquet Medical Systems USA
45 Barbour Pond Dr
Wayne NJ 07470-2094
|
| For Additional Information Contact |
Ms. Marylou Insinga
973-709-7000
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
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 in Commerce |
1022 units |
| Distribution |
US Nationwide. |
| Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = DTQ and Original Applicant = MAQUET CARDIOPULMONARY AG
|
