CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
McKesson Cardiology ECG Management It recalled by McKesson Israel
McKesson Israel is recalling McKesson Cardiology ECG Management It is a, distributed in Massachusetts, Mississippi, North Carolina, New Hampshire, Texas, Washington. The recall was initiated on 19 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0910-2015
- FDA event ID
- 70144
- Recalling firm
- McKesson Israel, Tel Aviv, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2014
- FDA classified
- 5 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 19 Dec 2014 | Recall initiated by company | |
| 5 Jan 2015 | Classified by FDA | +17 days |
| 14 Jan 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
MassachusettsMississippiNorth CarolinaNew HampshireTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
MC13.1 and MC13.1.1
Where was it sold?
Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from McKesson Israel
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Cardiology Hemo, Release SW recalled by McKesson Israel | McKesson Israel | Device Malfunction | 14 states |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |