Food, drugs, devices › Mckesson Medical Immaging
Device recall: Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intend
FDA enforcement event 68431 is a device recall by Mckesson Medical Immaging of Richmond, British Columbia, initiated 29 May 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 31 Mar 2017. Initiation: voluntary: firm initiated. Mckesson Medical Immaging has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mckesson Medical Immaging, Richmond, British Columbia, Canada.
Reason for recall
"Firm received a complaint that an unreported study performed that day could not be opened from the archive."
Distribution
"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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1728-2014 | 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. | 659 | Class II | Terminated | 18 Jun 2014 |
Context
Other enforcement events for Mckesson Medical Immaging
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Feb 2016 | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12 | Device | Class II | 1 |
| 5 May 2014 | Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transm | Device | Class II | 1 |
| 17 Apr 2014 | McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, | Device | Class II | 1 |
All 4 events for Mckesson Medical Immaging
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Firm received a complaint that an unreported study performed that day could not be opened from the archive."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 31 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.