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

Recall Z-0093-2015 — McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

U.S. FDA — Device Enforcement · United States · 2014-06-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0093-2015
Date of alert
2014-06-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mckesson Information Solutions LLC
Product category
device
Product type
Devices
Reported risk: McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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