Horizon Medical Imaging system — Class II medical device recall Z-2238-2012
Terminated recall by Mckesson Medical Imaging Group, reported 2012-08-29, distributed nationwide. There is a potential to save reports in RadReport with an Incorrect Final Status.
| Recall number | Z-2238-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical Imaging Group, Richmond, British Columbia, Canada |
| Recall initiated | 2012-05-29 |
| Classified | 2012-08-21 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2013-09-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, GB, IE |
| Quantity | 516 units |
Product
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Reason for recall
There is a potential to save reports in RadReport with an Incorrect Final Status.
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-2238-2012. 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.