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Terminated

InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),

FDA Recall Z-0524-2014 · Posted 2013-12-17

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-11-26
Date Terminated2017-04-17
Product Quantity654

Reason for Recall

GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.

Firm Action

GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.

Root Cause

Software Design Change

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960330INSTATRAKVisualization Technology, Inc. · 1996-04-08

Official Source

View FDA Recall →

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

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