FDA recall record

McKesson Radiology 12.2 - Picture Archive Communication System (PACS) recall — FDA Z-1396-2017

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…

Class IIclassification
Z-1396-2017official record ID
Mar 8, 2017report date

Recall record at a glance

Official recordZ-1396-2017
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmMckesson Medical Imaging
Report dateMar 8, 2017
Recall initiation dateDec 2, 2016
Quantity17
LocationRichmond, N/A, Canada

Official product description

McKesson Radiology 12.2 - Picture Archive Communication System (PACS)

Why the product was recalled

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.

Distribution information

AK, CA, FL, HI, KY, MD, MI, MS, NH, OH, PA, TN, TX, VT

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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