Mckesson Medical Imaging Group: Medical Device Recall in 2012 - (Recall #: Z-2238-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: May 29, 2012

Date Posted: August 29, 2012

Recall Number: Z-2238-2012

Event ID: 62567

Reason for Recall:

There is a potential to save reports in RadReport with an Incorrect Final Status.

Status: Terminated

Product Quantity: 516 units

Code Information:

Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.

Distribution Pattern:

Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated