McKesson Cardiology ECG Management It is a software application… — Class II medical device recall Z-0910-2015
Terminated recall by McKesson Israel Ltd., reported 2015-01-14, distributed in MA, MS, NC, NH, TX, WA. An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management wi
| Recall number | Z-0910-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | McKesson Israel Ltd., Tel Aviv, N/A, Israel |
| Recall initiated | 2014-12-19 |
| Classified | 2015-01-05 |
| Reported by FDA | 2015-01-14 |
| Terminated | 2016-02-25 |
| Distributed | MA, MS, NC, NH, TX, WA |
| Countries outside the US | GB |
| Quantity | 9 |
| Reason classes | software |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0910-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.