FDA Medical Device Recalls (openFDA)
Philips Healthcare Informatics, Inc.: iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
- Recall number
- Z-0118-2009
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Product
- iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
- Status
- Terminated
- Initiated
- 2008-08-29
- Posted
- 2008-10-28
- Terminated
- 2010-11-30
- Reason
- Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot
- Root cause
- Software design
- Action
- A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.
- Quantity
- 27 units.
- Distribution
- Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
- Lot, serial or model codes
- Software versions 3.6.28.x and 4.1.x.
- 510(k) numbers
- ["K042292","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