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Terminated

IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.

FDA Recall Z-1885-2009 · Posted 2009-08-27

Recalling FirmIntelerad Medical Systems Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-10-27
Date Terminated2010-09-24
Product Quantity17 (including 11 free trials)

Reason for Recall

Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.

Firm Action

Intelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to [email protected]. For further information, contact Intelerad Medical Systems at 1-514-931-6222.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070080INTELEPACSIntelerad Medical Systems, Inc. · 2007-01-24

Official Source

View FDA Recall →

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

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