Z-0616-2007

The iSight PACS (picture archiving and communications system) a software package used with general purpose...

Name: Z-0616-2007 The iSight PACS (picture archiving and communications system) a software package used with general purpose...
Creator: Stentor Inc A Phillips Medical Systems Co.
Published: 2007-02-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2007-02-14 / Terminated / root cause: labeling and UDI

FDA source

Stentor Inc A Phillips Medical Systems Co. began a recall of The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute... on 2007-02-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0616-2007
Status: Terminated
Initiated: 2007-02-14
Posted: 2007-03-13
Terminated: 2007-12-03
Recalling firm: Philips North America LLC
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.
Quantity in commerce: 54 units
Distribution: Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
Product codes and lots: Version 3.5

Product code LLZ

K042292Class IIIsite PacsStentor, Inc. / cleared 2004-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)