FDA Device

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

Hazard

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

What You Should Do

Remedy

On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.

Products

''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Brand
Stentor Inc
UPC
All models, version 3.3

Units Affected

110 units