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Terminated

InstaTrak 3500 Navigation and Visualization System

FDA Recall Z-0690-05 · Posted 2005-04-08

Recalling FirmOEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2004-12-13
Date Terminated2011-07-08
Product Quantity114 units

Reason for Recall

Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

Firm Action

Customers were notified by letter on 12/13/04.

Root Cause

Other

Distribution Pattern

Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003510INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500Visualization Technology, Inc. · 2001-02-12

Official Source

View FDA Recall →

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

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