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Terminated

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.

FDA Recall Z-2379-2016 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-30
Date Terminated2020-10-05
Product Quantity93 sites have the affected version

Reason for Recall

The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

Firm Action

The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/30/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users. A second letter was issued to nonresponders dated 5/25/2016

Root Cause

Software design

Distribution Pattern

The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082144AMICAS PACS, VERSION 6.0Amicas, Inc. · 2008-09-05

Official Source

View FDA Recall →

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

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