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Class 2 Device Recall CARDIOHELPi |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
April 15, 2024 |
Date Posted |
May 16, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1831-2024 |
Recall Event ID |
94450 |
510(K)Number |
K133598
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Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product |
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. |
Code Information |
Part No. 70104.8012 and 70104.8012R; UDI-DI: 04037691658384; Serial no. 90410021, 90410029, 90410165, 90410254, 90410255, 90410024, 90410025, 90410026, 90410028, 90410030, 90410031, 90410034, 90410035, 90410036, 90410043, 90410044, 90410045, 90410046, 90410047, 90410048, 90410049, 90410050, 90410051, 90410052, 90410053, 90410054, 90410055, 90410056, 90410057, 90410058, 90410059, 90410060, 90410061, 90410062, 90410063, 90410064, 90410065, 90410067, 90410068, 90410069, 90410070, 90410071, 90410072, 90410073, 90410074, 90410075, 90410076, 90410077, 90410078, 90410079, 90410080, 90410081, 90410082, 90410084, 90410085, 90410086, 90410087, 90410088, 90410089, 90410091, 90410093, 90410094, 90410095, 90410096, 90410097, 90410098, 90410099, 90410100, 90410101, 90410102, 90410103, 90410104, 90410105, 90410106, 90410107, 90410108, 90410109, 90410110, 90410111, 90410112, 90410113, 90410114, 90410115, 90410116, 90410117, 90410118, 90410119, 90410120, 90410121, 90410122, 90410123, 90410124, 90410125, 90410126, 90410127, 90410130, 90410131, 90410132, 90410133, 90410134, 90410135, 90410136, 90410137, 90410138, 90410139, 90410140, 90410141, 90410142, 90410143, 90410144, 90410146, 90410147, 90410148, 90410149, 90410151, 90410152, 90410153, 90410154, 90410155, 90410156, 90410157, 90410158, 90410159, 90410160, 90410161, 90410162, 90410163, 90410166, 90410167, 90410168, 90410169, 90410170, 90410172, 90410173, 90410174, 90410175, 90410176, 90410177, 90410178, 90410179, 90410180, 90410181, 90410182, 90410183, 90410184, 90410185, 90410186, 90410187. |
Recalling Firm/ Manufacturer |
Maquet Medical Systems USA 45 Barbour Pond Dr Wayne NJ 07470-2094
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For Additional Information Contact |
Marc De Carlo 973-709-7725
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Manufacturer Reason for Recall |
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Consignees received an "URGENT MEDICAL DEVICE - Removal" email, dated 4/15/2024, notifying them of this recall event. Consignees are asked to examine their inventory to identify if they possess any affected devices and all consignees are asked to return the provided Response Form via email to identify where affected devices are located. Consignees that report having any affected devices will be contacted by Getinge to arrange for return of the affected device to upgrade the system's sensor panel and perform testing to ensure that leakage current is within specifications. Technical Support can also be contacted at 888-943-8872 (option 4, option 2, option 1) Monday through Friday between 8:00 AM and 6:00 PM EST to make service arrangements. Consignees are asked to not use affected devices for any additional patients until it has been cleared by the MCP/Getinge system check, repaired, or replaced. The provided recall notice is to be forwarded to users of the CARDIOHELP-i system and if the device was further distributed. |
Quantity in Commerce |
148 units (US: 5; OUS: 143) |
Distribution |
US Nationwide distribution in the states of NJ & TX. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = DTQ and Original Applicant = MAQUET CARDIOPULMONARY AG
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