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Terminated

McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.

FDA Recall Z-0093-2015 · Posted 2014-10-20

Recalling FirmMckesson Information Solutions LLC
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-06-25
Date Terminated2017-10-26
Product Quantity625 devices

Reason for Recall

McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

Firm Action

Consignees were notified via Field Safety Notice on 06/25/2014.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Botswana, Canada, Germany, New Zealand, Netherlands, Pakistan, Portugal, South Africa, Turkey and The United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131497MCKESSON CARDIOLOGY HEMOMckesson Israel , Ltd. · 2013-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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