The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hard
FDA device recall Z-0616-2007 · posted 2007-03-13 · Terminated
Recall details
- Recalling firm
- Stentor Inc A Phillips Medical Systems Co.
- Reason for recall
- A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.
- Action taken
- The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 54 units
- Distribution
- Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.
- Date initiated
- 2007-02-14
- Date posted
- 2007-03-13
- Date terminated
- 2007-12-03
- 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 |