FDA Medical Device Recalls (openFDA)
Philips Healthcare Informatics, Inc.: Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
- Recall number
- Z-2346-2008
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Product
- Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
- Status
- Terminated
- Initiated
- 2008-07-03
- Posted
- 2008-09-18
- Terminated
- 2009-10-07
- Reason
- Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
- Root cause
- Software design
- Action
- A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808.
- Quantity
- 198 systems
- Distribution
- Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria
- Lot, serial or model codes
- all products with software versions 3.5.x
- 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