FDA Medical Device Recalls (openFDA)
Stentor Inc: ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
- Recall number
- Z-0399-06
- Recalling firm
- Stentor Inc
- Product
- ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
- Status
- Terminated
- Initiated
- 2005-12-20
- Posted
- 2006-01-18
- Terminated
- 2006-04-14
- Reason
- 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
- Root cause
- Other
- Action
- On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Quantity
- 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.
- Lot, serial or model codes
- All models, version 3.3
- 510(k) numbers
- ["K042292"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002971142
- Firm city
- Brisbane
- 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