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Terminated

Merge PACS software. 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-0726-2017 · Posted None

Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-03-28
Date Terminated2021-05-07
Product Quantity537 sites potentially have the affected versions

Reason for Recall

Cut lines on the image may present horizontally rather than vertically.

Firm Action

MERGE sent an Urgent Medical Device Recall dated March 28, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Merge Healthcare is working on correcting the issues and will inform customers once a fix is made available. Customers were asked to reply using the enclosed form and the return addressed envelope. If customers have further distributed the affected product they need to identify their customers and notify them at once of the product recall. Customers with questions were instructed to send an email to [email protected].

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US (nationwide) Canada and foreign distribution

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.

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