CLASS II Device recall · Reported 28 Sep 2016 · FDA Enforcement Report
McKesson Radiology, versions 1.1 and 2 McKesson Radiology recalled
Mckesson Medical Imaging Group is recalling McKesson Radiology, versions 1.1 and 2 McKesson Radiology (MR) is a Picture Archiving, distributed nationwide in the US. The recall was initiated on 12 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2872-2016
- FDA event ID
- 75194
- Recalling firm
- Mckesson Medical Imaging Group, Richmond, British Co
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2016
- FDA classified
- 22 Sep 2016
- Reported
- 28 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 12 Jul 2016 | Recall initiated by company | |
| 22 Sep 2016 | Classified by FDA | +72 days |
| 28 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The STAT priority icon was not displayed in the Study List when the study was opened.
Product as listed by the FDA
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 medical images, digital medical video, and associated medical information from various medical imaging systems.
Where it was distributed
Worldwide Distribution - US including 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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is McKesson Radiology, versions 1.1 and 2 McKesson Radiology (MR) is a Picture Archiving recalled?
Yes. Mckesson Medical Imaging Group recalled McKesson Radiology, versions 1.1 and 2 McKesson Radiology (MR) is a Picture Archiving on 12 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2872-2016.
Why was it recalled?
The STAT priority icon was not displayed in the Study List when the study was opened.
Which lots are affected?
McKesson Radiology versions 12.1.1 and 12.2
Where was it sold?
Worldwide Distribution - US including 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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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