FDA Medical Device Recalls (openFDA)
Philips Healthcare Informatics, Inc.: Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
- Recall number
- Z-1444-2008
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Product
- Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
- Status
- Terminated
- Initiated
- 2008-01-29
- Posted
- 2008-08-16
- Terminated
- 2008-09-25
- Reason
- When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool.
- Root cause
- Software design
- Action
- The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem.
- Quantity
- 2 units
- Distribution
- Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
- Lot, serial or model codes
- Version 4.1.17.0
- 510(k) numbers
- ["K063267"]
- 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