McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute
FDA device recall Z-0910-2015 · posted 2015-01-05 · Terminated
Recall details
- Recalling firm
- McKesson Israel Ltd.
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 9
- Distribution
- Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-05
- Date terminated
- 2016-02-25
- Location
- Tel Aviv, Israel
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON CARDIOLOGY ECG MANAGEMENT (K113515) | Mckesson Israel , Ltd. | 2012-03-16 |