Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 29, 2012
Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammogr
There is a potential to save reports in RadReport with an Incorrect Final Status.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mckesson Medical Imaging Group recalled Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical i… - a moderate-severity action.
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical i… was recalled by Mckesson Medical Imaging Group in August 29, 2012. Reason: There is a potential to save reports in RadReport with an Incorrect Final Status.. Check the official notice for the remedy. Verify recall #Z-2238-2012 with the FDA Devices before acting.
The recall
Mckesson Medical Imaging Group issued this moderate-severity FDA Devices recall-There is a potential to save reports in RadReport with an Incorrect Final Status..
- Moderate
- severity level
- 516 units
- affected scope
- Class II
- classification
- August 29, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2238-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2238-2012) was formally reported on August 29, 2012, with the manufacturer initiating the action on May 29, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Mckesson Medical Imaging Group is listed as the recalling firm, operating out of Richmond, British Columbia. Federal records list the affected scope as 516 units.
The documented reason for this recall is: There is a potential to save reports in RadReport with an Incorrect Final Status. Distribution data in the federal record shows the product reached: Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
516 units
Related Recalls
6
3 from same agency
Product description
Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).
Reason for recall
There is a potential to save reports in RadReport with an Incorrect Final Status.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2238-2012 |
| Date reported | August 29, 2012 |
| Date initiated | May 29, 2012 |
| Recalling firm | Mckesson Medical Imaging Group |
| Firm location | Richmond, British Columbia |
| Affected scope | 516 units |
| Distribution | Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2238-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Horizon Medical Imaging system. Product Usage: 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).. Recalled by Mckesson Medical Imaging Group. Units affected: 516 units.
Why was this product recalled? ▼
There is a potential to save reports in RadReport with an Incorrect Final Status.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2012. Severity: Moderate. Recall number: Z-2238-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2238-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 29, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.