McKesson Cardiology" Hemo intended for complete… — Class II medical device recall Z-0042-2015
Terminated recall by Mckesson Information Solutions LLC, reported 2014-10-15, distributed nationwide. Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value bef
| Recall number | Z-0042-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Information Solutions LLC, Alpharetta, GA, United States |
| Recall initiated | 2014-08-27 |
| Classified | 2014-10-08 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-05-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, IL |
| Quantity | 272 devices |
| Reason classes | software |
Product
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0042-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.