Company: Stentor, Inc.
Date of Enforcement Report:1/25/2006
Class:lI
PRODUCT
“iSite” PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3, Recall # Z-0399-06
REASON
When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and diagnostic display screens.
CODE
All models, version 3.3
RECALLING FIRM/MANUFACTURER
Stentor, Inc., Brisban, CA, by letters on December 20, 2005. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
Nationwide
