CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
- Company
- Maquet Medical Systems, Usa
- Recall Initiated
- April 15, 2024
- Posted
- May 16, 2024
- Recall Number
- Z-1831-2024
- Quantity
- 148 units (US: 5; OUS: 143)
- Firm Location
- Wayne, NJ
Reason for Recall
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Distribution
US Nationwide distribution in the states of NJ & TX.
Lot / Code Info
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.
Root Cause
Under Investigation by firm
Action Taken
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.