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Terminated

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.

FDA Recall Z-1942-2011 · Posted 2011-04-11

Recalling FirmGE OEC Medical Systems, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-02-24
Date Terminated2011-09-09
Product Quantity708 cables

Reason for Recall

Sensor cables may suffer material degradation when exposed to certain sterilization procedures.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040050INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500Ge Medical Systems Navigation and Visualization IN · 2004-03-24

Official Source

View FDA Recall →

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

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