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

Recall Z-0060-2015 — GE Healthcare Carescape Patient Data Module

U.S. FDA — Device Enforcement · United States · 2014-09-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0060-2015
Date of alert
2014-09-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Reported risk: GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a Patient Discharge or during active monitoring, the ECG waveform an
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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