Recall Z-0834-2012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate)
| Date | Jan 21, 2012 (initiated Dec 23, 2011) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injuries to patients or operators. |
| Root cause | Software design |
| Action | GE Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 23, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. Contact the GE Support Center at 1-800-321-7937 or your local GE Healthcare service representative for questions regarding this issue. |
| Quantity | 2270 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, ME, MA, MI, MN, MS, MO, MT, NE, NV, NH, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, and WI. and countries of VENEZUELA, UNITED KINGDOM TURKEY, TUNISIA, THAILAND, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073297 | GE LOGIQ P6 General Electric Co., Dec 18, 2007 |