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Terminated

GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116

FDA Recall Z-0183-2008 · Posted 2008-01-23

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2007-10-18
Date Terminated2012-08-10
Product Quantity169 units

Reason for Recall

Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.

Firm Action

Consignees were sent an Urgent Recall Notice via mail dated 10/11/07, notifying the customer to examine the plastic end of the transmitter arm and to not use the transmitter arm, if any cracks or damage are observed. Also to stop using Steam Sterilization method and to utilize the other Sterilization methods indicated in the Operators Manual. The root cause is still under investigation GEHC Surgery will provide, at no charge, a solution to this issue when it becomes available.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, MA, MD, MI, MS, NC, NY, OK, OR, PA, SC, TX, UT, VA, WI, and WV, and countries of Canada, China, France, Hong Kong, Japan, Mexico, Spain, and Switzerland.

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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