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Terminated

''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3

FDA Recall Z-0399-06 · Posted 2006-01-18

Recalling FirmStentor Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-12-20
Date Terminated2006-04-14
Product Quantity110 units

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

Firm Action

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

Distribution Pattern

Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042292ISITE PACSStentor, Inc. · 2004-09-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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