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U.S. Department of Health and Human Services

Class 2 Device Recall Sensor cables

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  Class 2 Device Recall Sensor cables see related information
Date Initiated by Firm February 24, 2011
Date Posted April 11, 2011
Recall Status1 Terminated 3 on September 09, 2011
Recall Number Z-1942-2011
Recall Event ID 58098
510(K)Number K040050  
Product Classification System, image processing, radiological - Product Code LLZ
Product Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 GE OEC Medical Systems, Inc
384 Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
801-517-6717
Manufacturer Reason
for Recall		 Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
FDA Determined
Cause 2		 Component design/selection
Action GE OEC Medical Systems, Inc sent an Urgent Recall Notice dated March 1, 2011, by certified letter on February 24, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if their Transmitter Sensor Cables or Receiver Sensor Cables have been exposed to any STERRAD sterilizer other than STERRAD 1005, discontinue use of these sterilizers for this product. The Transmitter Sensor Cables should be inspected for signs of material degradation. Further information is available at 800-874-7378.
Quantity in Commerce 708 cables
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI and WV and the countries of Austria, Canada, China, Denmark, England, France, Germany, Hong Kong, India, Ireland, Italy, Japan, San Salvador, Slovakia, Spain, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
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