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FDA Medical Device Recalls (openFDA)

Mckesson Medical Imaging: McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

Recall number
Z-1396-2017
Recalling firm
Mckesson Medical Imaging
Product
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Status
Terminated
Initiated
2016-12-02
Posted
not on file
Terminated
2017-11-24
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.
Root cause
Software design
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.
Quantity
17
Distribution
AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT
Lot, serial or model codes
Model 12.2
510(k) numbers
["K140909"]
PMA numbers
not on file
Product code
LLZ
Firm FEI
3003757840
Firm city
Richmond
Firm state
not on file
Firm country
Canada

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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