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Terminated

NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)

FDA Recall Z-2151-2016 · Posted None

Recalling FirmNovarad Corporation
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-05-09
Date Terminated2016-12-01
Product Quantity2695

Reason for Recall

Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.

Firm Action

Consignees were notified on 05/09/13 via letter and email to upgrade software and to turn off streaming function.

Root Cause

Software design

Distribution Pattern

Worldwide distribution including US nationwide. No Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063153NOVAPACSNovarad Corp. · 2006-12-07

Official Source

View FDA Recall →

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

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