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Terminated

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Recall Z-1176-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-04-04
Date Terminated2019-04-08
Product Quantity29 sites have the potentially affected software

Reason for Recall

Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment.

Firm Action

The recalling firm issued a letter dated 3/28/2016 via email on 4/4/2016 or via certified mail if they did not have an email address for the customer. A second letter was issued 7/11/2016 to nonresponders.

Root Cause

Software design

Distribution Pattern

Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/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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