FDA Device recall Z-0910-2015
McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage informat…
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage informat… by Mckesson Israel, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0910-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mckesson Israel |
| Distribution | MA, MS, NC, NH, TX, WA |
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
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.
Identifiers
| code_info | MC13.1 and MC13.1.1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0910-2015%22
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