FDA Recall
Terminated
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Recall: Z-1396-2017
·
Initiated December 2, 2016
Recall
- Recall Number
- Z-1396-2017
- Event Number
- 76500
- Firm
- Mckesson Medical Imaging
- FEI Number
- 3003757840
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- December 2, 2016
- Terminated
- November 24, 2017
- Address
- 10711 Cambie Rd, Suite 130, Richmond Canada
Description
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Reason
Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a newly imported study, and/or study imports that remain in an "in-progress" status.
Action
McKesson sent an Urgent Field Safety Notice on December 2, 2016 to customers with potentially affected software versions. The notice indicated that they were to contact McKesson to install a software update to correct the issue, and that they read and understood the Field Safety Notice.
Distribution
AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
Quantity
17