CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

FDA device recall Z-1831-2024 · posted 2024-05-16 · Open, Classified

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DTQ

Quantity affected

148 units (US: 5; OUS: 143)

Distribution

US Nationwide distribution in the states of NJ & TX.

Date initiated

2024-04-15

Date posted

2024-05-16

Location

Wayne, NJ

Related 510(k) clearances