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Terminated

InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)

FDA Recall Z-0704-2007 · Posted 2007-03-30

Recalling FirmGE OEC Medical Systems,Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-01-26
Date Terminated2011-07-08
Product Quantity91 systems (version 5.1 software)

Reason for Recall

Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.

Firm Action

Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2

Root Cause

Other

Distribution Pattern

Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983529INSTATRAK 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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