McKesson Cardiology Hemo — Class II medical device recall Z-0093-2015
Terminated recall by Mckesson Information Solutions LLC, reported 2014-10-29, distributed nationwide. McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the pr
| Recall number | Z-0093-2015 |
|---|---|
| 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 | 2014-06-25 |
| Classified | 2014-10-20 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2017-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, NL, NZ, PK, PT, TR, ZA |
| Quantity | 625 devices |
Product
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
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
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-0093-2015. 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.