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Terminated

GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)

FDA Recall Z-0001-2007 · Posted 2006-10-03

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-05-31
Date Terminated2011-07-27
Product Quantity143 units

Reason for Recall

Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

Firm Action

Consignees were notified by letter on 05/31/2006

Root Cause

Process control

Distribution Pattern

Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024012OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEMGe Oec Medical Systems · 2003-03-20

Official Source

View FDA Recall →

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

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