Stentor Inc ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Brand
Stentor Inc
Lot Codes / Batch Numbers
All models, version 3.3
Products Sold
All models, version 3.3
Stentor Inc is recalling ''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software versio due to 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 ma. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026