iConnect Enterprise Archive software.
FDA Recall Z-1700-2017 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLMB
Date Initiated2016-04-04
Date Terminated2020-10-05
Product Quantity371 sites potentially have the affected software
Reason for Recall
The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of disease.
Firm Action
The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail. A second letter dated 7/11/2016 was issued to nonresponders.
Root Cause
Software design
Distribution Pattern
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as other countries. Government and military distribution was also made.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.