Z-0399-06

''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3

Name: Z-0399-06 ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Creator: Stentor Inc
Published: 2005-12-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2005-12-20 / Terminated

FDA source

Stentor Inc began a recall of ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3 on 2005-12-20. The reason FDA records is "When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0399-06
Status: Terminated
Initiated: 2005-12-20
Posted: 2006-01-18
Terminated: 2006-04-14
Recalling firm: Philips North America LLC
Product: ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens
FDA root cause: Other
Action: On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Quantity in commerce: 110 units
Distribution: Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Product codes and lots: All models, version 3.3

Product code LLZ

K042292Class IIIsite PacsStentor, Inc. / cleared 2004-09-08

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)