Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
FDA device recall Z-1941-2011 · posted 2011-04-11 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Sensor cables may suffer material degradation when exposed to certain sterilization procedures.
- Action taken
- 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
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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, V
- Date initiated
- 2011-02-24
- Date posted
- 2011-04-11
- Date terminated
- 2011-09-09
- Location
- Salt Lake City, UT
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