Mar

2007

Class II Stentor Inc.

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class II Stentor Inc.

Amy Sellers

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