McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
FDA Recall Z-0042-2015 · Posted 2014-10-08
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Recalling FirmMckesson Information Solutions LLC
Recall StatusTerminated
Product CodeMWI
Date Initiated2014-08-27
Date Terminated2016-05-18
Product Quantity272 devices
Reason for Recall
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
Firm Action
On August 27, 2014, McKesson initiated a correction via a Field Safety Notice to all affected domestic customers. McKesson Israel will be responsible for contacting foreign consignees.
Root Cause
Software design (manufacturing process)
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: AR, CA, FL, DE, GA, HI, IL, IN, KS, LA, MA, MD, MN, MO, MS, MT, NJ, NV, OK, PA, SC, TNTX, , UT, WA; and countries of: Australia, Canada, Israel and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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