Data Foundry

Medical device recalls 2013

McKesson Horizon Medical Imaging — Class II medical device recall Z-2318-2013

Terminated recall by Mckesson Information Solutions LLC, reported 2013-10-09, distributed in GU, PR. Software malfunction may occur resulting in a certain combination of server configurations which has the poten

Recall numberZ-2318-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMckesson Information Solutions LLC, Alpharetta, GA, United States
Recall initiated2013-09-04
Classified2013-09-30
Reported by FDA2013-10-09
Terminated2017-02-06
DistributedGU, PR
Countries outside the USCA, FR
Quantity329 units
Reason classesdevice malfunction, software

Product

McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems.

Reason for recall

Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.

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-2318-2013. 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.