McKesson Cardiology ECG Management recallZ-0910-2015 · McKesson Israel Ltd. · initiated Dec 19, 2014
Class II Terminated All recalls posted in January 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from McKesson Israel Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
McKesson sent an Urgent Field Safety Notice dated December 16, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed how to identify the potentially affected procedures and update the procedure date (if relevant) until a software update is made advailable for installation by McKesson. McKesson will proactively identify prior procedures affected by this issue and will notify customers of any issues identified. In addition to the Field Safety Notice, McKesson Israel will provide correction to the affected SW versions and will contact customers for deployment of a software patch that prevents this scenario from occurring. Customers with questions should contact McKesson Support at 1-866-777-0202. For questions regarding this recall call 404-338-3556.
Recall details
- Recall number
- Z-0910-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 19, 2014
- Posted by the FDA
- Jan 5, 2015
- Recalling firm
- McKesson Israel Ltd.
- Quantity
- 9
- Product code
- DQK
- FDA submissions
- K113515
- Distribution
- Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
Product description
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.
Code information (models, lots, serial numbers)
MC13.1 and MC13.1.1
Other devices under the same FDA submission
1 device cleared under K113515 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Change Healthcare Cardiology ECG Management 14.1.1Change Healthcare Israel Ltd · Computer, Diagnostic, Programmable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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