Stentor Inc A Phillips Medical Systems Co. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stentor Inc A Phillips Medical Systems Co.
Lot Codes / Batch Numbers
Version 3.5
Products Sold
Version 3.5
Stentor Inc A Phillips Medical Systems Co. is recalling The iSight PACS (picture archiving and communications system) a software package used with general p due to A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical or. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026