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FDA Device recall Z-1182-2016

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1

On 2016-03-23 the FDA classified a Class II recall of McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1 by Mckesson Medical Immaging, citing mcKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1182-2016
ClassificationClass II
Statusterminated
Initiated2016-02-18
Published2016-03-23
Last updated2026-09-13 11:54 UTC
CompanyMckesson Medical Immaging
DistributionUS

Product

McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.

Reason

McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient.

Identifiers

code_infoMcKesson Radiology Versions- 12.1.1, 12.0; Horizon Medical Imaging Versions -11.9, 11.8, 11.7, 11.6, 11.5.2, 11.5.1,11.0.8, 5.0, 4.6.1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1182-2016%22

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