FDA Medical Device Recalls (openFDA)
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 number
- Z-0616-2007
- Recalling firm
- Stentor Inc A Phillips Medical Systems Co.
- 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.
- Status
- Terminated
- Initiated
- 2007-02-14
- Posted
- 2007-03-13
- Terminated
- 2007-12-03
- 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.
- 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
- 54 units
- Distribution
- Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
- Lot, serial or model codes
- Version 3.5
- 510(k) numbers
- ["K042292"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002971142
- Firm city
- Foster City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28