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Terminated

Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.

FDA Recall Z-2159-2016 · Posted 2016-07-11

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-01-31
Date Terminated2017-01-26
Product Quantity49 sites have the affected software

Reason for Recall

Potential data loss occurs as a result of product archiving not working properly.

Firm Action

The recalling firm issued a letter dated 1/27/2016 via e-mail on 1/31/2016 explaining the reason for recall and instructing the customer to provide a copy of the notification to all users.

Root Cause

Software design

Distribution Pattern

Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033825ORTHOPACSEtrauma.Com Corp. · 2004-02-02

Official Source

View FDA Recall →

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

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