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FDA Medical Device Recalls (openFDA)

Mckesson Medical Immaging: McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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.

Recall number
Z-1617-2014
Recalling firm
Mckesson Medical Immaging
Product
McKesson Radiology-PACS. McKesson Radiology is a medical image and information 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.
Status
Terminated
Initiated
2014-04-17
Posted
2014-05-13
Terminated
2016-02-02
Reason
High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.
Root cause
Software Design Change
Action
On April 17, 2014, McKesson Medical Imaging Company initiated a process for applying a software solution to all McKesson Radiology customer systems that may be affected to prevent future occurrences of this issue. The systems with the potentially affected software versions will be corrected without removing the systems from their location.
Quantity
45
Distribution
Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, and the countries of Canada and France.
Lot, serial or model codes
Model MR 12.0
510(k) numbers
["K043146"]
PMA numbers
not on file
Product code
LLZ
Firm FEI
3003757840
Firm city
Richmond Canada
Firm state
British Columbia
Firm country
not on file

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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