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.
FDA Recall Z-1182-2016 · Posted None
Recalling FirmMckesson Medical Immaging
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-02-18
Date Terminated2018-08-28
Product Quantity631 devices
Reason for Recall
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.
Firm Action
McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Immediate actions to take to reduce the risk to patient
All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009:
1) To acknowledge that they have read and understood this Field Safety Notice
And
2) Arrange installation of software update/upgrade.
This notice should be distributed to all personnel within your organization who need to be aware of this issue and the required actions, and alert other affiliated parties that are affected by this Field Safety Notice.
For further questions, please call (404) 338-3556
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY., and the countries of : Guam, Great Britain, France, Canada, Ireland and Australia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.