McKesson Cardiology" Hemo intended for complete… recallZ-0042-2015 · Mckesson Information Solutions LLC · initiated Aug 27, 2014
Class II Terminated All recalls posted in October 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mckesson Information Solutions LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula calculations.
FDA root cause category: Software design (manufacturing process)
What the company is doing
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.
Recall details
- Recall number
- Z-0042-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 27, 2014
- Posted by the FDA
- Oct 8, 2014
- Recalling firm
- Mckesson Information Solutions LLC
- Quantity
- 272 devices
- Product code
- MWI
- FDA submissions
- K131497
- Distribution
- 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.
Product description
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Code information (models, lots, serial numbers)
McKesson CardiologyTM Hemo versions: 13.0, 13.0HF1, 13.0HF2, 13.0HF3, 13.1.
Other devices under the same FDA submission
9 devices cleared under K131497 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Change Healthcare Cardiology Hemo 15.1Change Healthcare Canada Company · Computer, Diagnostic, Programmable4 recalls1 report
- Change Healthcare Cardiology Hemo 15.0.1Change Healthcare Canada Company · Computer, Diagnostic, Programmable3 recalls1 death1 report
- Change Healthcare Cardiology Hemo 14.3.2Change Healthcare Canada Company · Computer, Diagnostic, Programmable3 recalls0 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.1.1Change Healthcare Israel Ltd · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
- Change Healthcare Cardiology Hemo 14.3Change Healthcare Canada Company · Computer, Diagnostic, Programmable2 recalls0 reports
- Change Healthcare Cardiology Hemo 14.1Change Healthcare Israel Ltd · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 recall0 reports
- Change Healthcare Cardiology Hemo 15.0Change Healthcare Canada Company · Computer, Diagnostic, Programmable1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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