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Terminated

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).

FDA Recall Z-2238-2012 · Posted 2012-08-22

Recalling FirmMckesson Medical Imaging Group
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-05-29
Date Terminated2013-09-12
Product Quantity516 units

Reason for Recall

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

Firm Action

McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043146HORIZON MEDICAL IMAGINGMckesson Medical Imaging Company · 2005-01-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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