Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
FDA Recall Z-0599-2017 · Posted None
Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-03-28
Date Terminated2021-04-23
Product Quantity534 sites potentially have the affected versions
Reason for Recall
The software did not show unviewed images when the last view was skipped. The physician may potentially misdiagnose when not all images are available for viewing.
Firm Action
The recalling firm issued a letter dated March 28, 2016 via e-mail or via certified mail to customers. The letter identified the affected product, problem and actions to be taken. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide including Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.