Recall Z-0910-2015— McKesson Israel Ltd.
Class II · Terminated
Class II FDA medical device recall by McKesson Israel Ltd., initiated 2014-12-19, terminated 2016-02-25. It names one FDA 510(k) clearance: K113515. 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..
- Recalling firm
- McKesson Israel Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-19
- Terminated
- 2016-02-25
- Firm location
- Tel Aviv, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.