CLASS II Device recall · Reported 18 Jun 2014 · FDA Enforcement Report
Horizon Medical Imaging Horizon Medical Imaging recalled
Mckesson Medical Immaging is recalling Horizon Medical Imaging Horizon Medical Imaging is a medical image and information, distributed in 47 states. The recall was initiated on 29 May 2014 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-1728-2014
- FDA event ID
- 68431
- Recalling firm
- Mckesson Medical Immaging, Richmond, British Co
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2014
- FDA classified
- 6 Jun 2014
- Reported
- 18 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 29 May 2014 | Recall initiated by company | |
| 6 Jun 2014 | Classified by FDA | +8 days |
| 18 Jun 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
Product as listed by the FDA
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Where it was distributed
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, 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 Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
Which lots are affected?
HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0
Where was it sold?
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, 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 Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
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 26 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 | McKesson Horizon Medical Imaging recalled by Mckesson Medical Immaging | Mckesson Medical Immaging | Other | Nationwide |
| Device | CLASS II | Horizon Medical Imaging It is a medical image recalled | Mckesson Medical Immaging | Device Malfunction | 47 states |
| Device | CLASS II | McKesson Radiology-PACS recalled by Mckesson Medical Immaging | Mckesson Medical Immaging | Other | Nationwide |
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