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Terminated

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

FDA Recall Z-2590-2017 · Posted None

Recall StatusTerminated
Product CodeLLZ
Date Initiated2017-05-08
Date Terminated2019-08-05
Product Quantity47 sites potentially have the affected versions

Reason for Recall

Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

Firm Action

Merge Healthcare sent an Urgent Medical Device Recall letter dated May 5, 2017. The letter explains the issue and informs the customer to be aware of the workaround. The customer is also notified a software fix for the issue was released in Merge PACS 7.1.1 (or later). The customer is requested to ensure all users of the product are provided with the notification and if it has been further distributed, to notify downstream customers at once. The letter informs the customer a response is required 15 calendar days after receipt of the recall letter. The enclosed response asks, in part, if the customer is interested in accepting the fix and if not, to state the reason why. The recalling firm will contact all unresponsive customers a second and third time. Methods for contacting the customer may be by phone or email. For further questions, please call (877) 741-5369.

Root Cause

Software design (manufacturing process)

Distribution Pattern

USA (nationwide) Distribution .There was no foreign/government/military 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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