Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a s
FDA device recall Z-2346-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Informatics, Inc.
- Reason for recall
- Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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
- Date initiated
- 2008-07-03
- Date posted
- 2008-09-18
- Date terminated
- 2009-10-07
- 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 (K042292) | Stentor, Inc. | 2004-09-08 |