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Terminated

InstaTrak 3500 Plus Navigation and Visualization System

FDA Recall Z-0815-05 · Posted 2005-05-11

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-07-12
Date Terminated2011-08-02
Product Quantity5 kits

Reason for Recall

Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

Firm Action

Customers were notified by letter on 07/12/04.

Root Cause

Other

Distribution Pattern

Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040050INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500Ge Medical Systems Navigation and Visualization IN · 2004-03-24K983529INSTATRAK 3000Visualization Technology, Inc. · 1998-12-31

Official Source

View FDA Recall →

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

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