Reported Aug 29, 2012 · Terminated
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management…
Mckesson Medical Imaging Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mckesson Medical Imaging Group · 10711 Cambie Rdsuite 130 · Richmond, British Columbia · N/A
Is this the product you have?
- Horizon Medical Imaging system
- Product UsageHorizon 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)
- Lot codes and dates
Horizon Medical Imaging (HMI) versions 11.511.5.111.5.211.6 and 11.7
- Amount recalled
- 516 units
Where it was sold
- Nationwide
Why it was recalled
There is a potential to save reports in RadReport with an Incorrect Final Status.
This product could cause temporary or reversible health problems — stop using it.
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