Company:Stentor Inc
Date of Enforcement Report:3/21/2007
Class:ll
PRODUCT
The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment, Recall # Z-0616-2007
REASON
A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
CODE
Version 3.5
RECALLING FIRM/MANUFACTURER
Stentor Inc., A Phillips Medical Systems Co., Foster City, CA, by letter on February 14, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Nationwide and Internationally
