McKesson Horizon Medical Imaging — Class II medical device recall Z-1182-2016
Terminated recall by Mckesson Medical Immaging, reported 2016-03-23, distributed nationwide. McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use
| Recall number | Z-1182-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical Immaging, Richmond, British Columbia, Canada |
| Recall initiated | 2016-02-18 |
| Classified | 2016-03-17 |
| Reported by FDA | 2016-03-23 |
| Terminated | 2018-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, FR, GB, IE |
| Quantity | 631 devices |
Product
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Reason for recall
McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.
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-1182-2016. 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.