Exact FDA event identifier

Event 70144

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: December 19, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: McKesson Israel Ltd.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0910-2015

Recall number: Z-0910-2015
Initiated: December 19, 2014
Classification: Class II
Status: Terminated
Recalling firm: McKesson Israel Ltd.
Quantity: 9

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

MC13.1 and MC13.1.1

Distribution pattern

Worldwide Distribution - USA including MA, MS, NH, NC, TX, WA and Internationally to the United Kingdom.