CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
McKesson Horizon Medical Imaging recalled by Mckesson Medical Immaging
Mckesson Medical Immaging is recalling McKesson Horizon Medical Imaging (HMI) products versions 6.1 to including 9 and McKesson, distributed nationwide in the US. The recall was initiated on 18 Feb 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1182-2016
- FDA event ID
- 73452
- Recalling firm
- Mckesson Medical Immaging, Richmond, British Co
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Feb 2016
- FDA classified
- 17 Mar 2016
- Reported
- 23 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 18 Feb 2016 | Recall initiated by company | |
| 17 Mar 2016 | Classified by FDA | +28 days |
| 23 Mar 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Is McKesson Horizon Medical Imaging (HMI) products versions 6.1 to including 9 and McKesson recalled?
Yes. Mckesson Medical Immaging recalled McKesson Horizon Medical Imaging (HMI) products versions 6.1 to including 9 and McKesson on 18 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1182-2016.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mckesson Medical Immaging
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Horizon Medical Imaging It is a medical image recalled | Mckesson Medical Immaging | Device Malfunction | 47 states |
| Device | CLASS II | Horizon Medical Imaging Horizon Medical Imaging is recalled | Mckesson Medical Immaging | Other | Nationwide |
| Device | CLASS II | McKesson Radiology-PACS recalled by Mckesson Medical Immaging | Mckesson Medical Immaging | Other | Nationwide |
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