Z-1884-2009

IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X

Name: Z-1884-2009 IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X
Creator: Intelerad Medical Systems Inc.
Published: 2008-10-27
License: https://open.fda.gov/license/

Intelerad Medical Systems Incorporated / initiated 2008-10-27 / Terminated / root cause: software

FDA source

Intelerad Medical Systems Inc. began a recall of IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X on 2008-10-27. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1884-2009
Status: Terminated
Initiated: 2008-10-27
Posted: 2009-08-27
Terminated: 2010-09-24
Recalling firm: Intelerad Medical Systems Incorporated
Product: IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 1
Distribution: Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
Product codes and lots: InteleViewer software versions 3.5.2.P1 to 3.3.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive.

Product code LLZ

K070080Class IIIntelepacsIntelerad Medical Systems, Inc. / cleared 2007-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)