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

Recall Z-0910-2015 — McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

U.S. FDA — Device Enforcement · Israel · 2014-12-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0910-2015
Date of alert: 2014-12-19
Country / jurisdiction: Israel
Risk level: Class II
Risk type: recall
Brand: McKesson Israel Ltd.
Product category: device
Product type: Devices

Reported risk: An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

Recall Z-0910-2015 — McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.

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