Z-1942-2011

Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt...

Name: Z-1942-2011 Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt...
Creator: GE OEC Medical Systems, Inc
Published: 2011-02-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2011-02-24 / Terminated / root cause: design

FDA source

GE OEC Medical Systems, Inc began a recall of Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. Cables are used with InstraTrak... on 2011-02-24. The reason FDA records is "Sensor cables may suffer material degradation when exposed to certain sterilization procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1942-2011
Status: Terminated
Initiated: 2011-02-24
Posted: 2011-04-11
Terminated: 2011-09-09
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All serial numbers.

Product code LLZ

K040050Class IIInstatrak System with Multiple Dataset Navigation, Model It3500Ge Medical Systems Navigation and Visualization IN / cleared 2004-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)