''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
FDA device recall Z-0399-06 · posted 2006-01-18 · Terminated
Recall details
- Recalling firm
- Stentor Inc
- Reason for recall
- When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens
- Action taken
- On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 110 units
- Distribution
- Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
- Date initiated
- 2005-12-20
- Date posted
- 2006-01-18
- Date terminated
- 2006-04-14
- Location
- Brisbane, 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 |