Z-1182-2016Class II

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

Name: Z-1182-2016 McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR)...
Creator: Mckesson Medical Immaging
Published: 2016-02-18
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2016-02-18 / Terminated / root cause: software

FDA source

Mckesson Medical Immaging began a 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 on 2016-02-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1182-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-03-17
Terminated: 2018-08-28
Recalling firm: Change Healthcare Canada Company
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
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
Quantity in commerce: 631 devices
Distribution: 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
Product codes and lots: McKesson 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1182-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1182-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-23	2016-03-17

Product code LLZ

K043146Class IIHorizon Medical ImagingMckesson Medical Imaging Company / cleared 2005-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)