The Recall Desk
ModerateFDA (Devices)·Z-2872-2016·Announced 2016-09-28

McKesson Radiology Software Recalled for Missing STAT Priority Icon

McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a software display issue (missing icon) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

McKesson Medical Imaging Group is recalling McKesson Radiology (MR) software, versions 12.1.1 and 12.2. McKesson Radiology is a Picture Archiving Communication System (PACS) intended to receive, transmit, store, retrieve, display, print, and process digital medical images and associated information from various medical imaging systems.

The recall was initiated because the STAT priority icon was not displayed in the Study List when the study was opened. This defect could potentially affect the visibility of urgent studies within the software interface.

The recall affects 164 devices. The software was distributed worldwide, including in the United States (AL, AK, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WV, WI, WY) and internationally to Canada, France, Great Britain, and Ireland. Users of the affected software versions should contact McKesson Medical Imaging Group for further instructions regarding the recall.

The recalled product

Product
McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital m
Manufacturer
Mckesson Medical Imaging Group
Category
Medical Device — Software
Hazard
Affected units
164

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • McKesson Radiology versions 12.1.1 and 12.2

Distribution

Distributed in 40 states:

Related recalls

Same manufacturer · Mckesson Medical Imaging Group

See all →

Same hazard · software defect

See all →