McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS).
FDA device recall Z-2872-2016 · posted 2016-09-22 · Terminated
Recall details
- Recalling firm
- Mckesson Medical Imaging Group
- Reason for recall
- The STAT priority icon was not displayed in the Study List when the study was opened.
- Action taken
- McKesson sent an Urgent Field Safety Notice on July 12, 2016 to customers with potentially affected software versions. The letter requested that they contact McKesson to acknowledge that they read and understood the Field Safety Notice and to arrange installation of software update/upgrade. Customers with questions were instructed call the McKesson Support department and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 164 devices
- Distribution
- 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
- Date initiated
- 2016-07-12
- Date posted
- 2016-09-22
- Date terminated
- 2019-11-20
- Location
- Canada, British Columbia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON MEDICAL IMAGING (K043146) | Mckesson Medical Imaging Company | 2005-01-04 |