FDA-Device2024-05-22Class II
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Maquet Medical Systems USA
Hazard
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Sold states
US Nationwide distribution in the states of NJ & TX.
Affected count
148 units (US: 5; OUS: 143)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1831-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief