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Terminated

Horizon Medical Imaging, Picture Archive Communication System (PACS).

FDA Recall Z-0976-2014 · Posted 2014-02-12

Recalling FirmMckesson Information Solutions LLC
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-12-23
Date Terminated2017-04-25
Product Quantity618 units

Reason for Recall

Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.

Firm Action

McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.

Root Cause

Software design

Distribution Pattern

U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The 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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