FDA Medical Device Recalls (openFDA)
McKesson Israel Ltd.: 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.
- Recall number
- Z-0910-2015
- Recalling firm
- McKesson Israel Ltd.
- 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.
- Status
- Terminated
- Initiated
- 2014-12-19
- Posted
- 2015-01-05
- Terminated
- 2016-02-25
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 9
- Distribution
- Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
- Lot, serial or model codes
- MC13.1 and MC13.1.1
- 510(k) numbers
- K113515
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3007784465
- Firm city
- Tel Aviv
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06