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Terminated

Merge OrthoPACS software.

FDA Recall Z-2620-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2017-05-24
Date Terminated2019-06-28
Product Quantity98 sites potentially have the affected versions

Reason for Recall

A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.

Firm Action

The recalling firm issued a letter dated 5/19/2017 via email on 5/24/2017 or via certified mail if they did not have an email address for the customer.

Root Cause

Software design

Distribution Pattern

Distribution was made nationwide to medical facilities. There was no foreign/government/military distribution.

Official Source

View FDA Recall →

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

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