Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1149-2013 — MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures r

U.S. FDA — Device Enforcement · United States · 2013-03-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1149-2013
Date of alert: 2013-03-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Maquet Cardiovascular, LLC
Product category: device
Product type: Devices

Reported risk: It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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