Company: Mckesson Medical Immaging
Date of Enforcement Report 3/23/2016
Class lI:
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. Recall Number Z-1182-2016
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.
RECALLING FIRM/MANUFACTURER
Mckesson Medical Immaging, Richmond, British Columbia on 3/17/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
631 devices
DISTRIBUTION
Nationwide and Internationally
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