Maquet Medical Systems USA recalls
5 recalls on record · FDA
Every recall we have on record for Maquet Medical Systems USA, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with…
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780…
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.
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model …
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model …
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.