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Terminated

The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment.

FDA Recall Z-0616-2007 · Posted 2007-03-13

Recalling FirmStentor Inc A Phillips Medical Systems Co.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-02-14
Date Terminated2007-12-03
Product Quantity54 units

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.

Firm Action

The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures.

Root Cause

Other

Distribution Pattern

Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada.

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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