Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image man
FDA device recall Z-1444-2008 · posted 2008-08-16 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 2 units
- Distribution
- Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
- Date initiated
- 2008-01-29
- Date posted
- 2008-08-16
- Date terminated
- 2008-09-25
- Location
- Foster City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISITE PACS, V 4. X (K063267) | Stentor Inc., A Philips Medical Systems Co. | 2006-11-09 |