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); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).
Recalling Firm/ Manufacturer
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha, Wisconsin 53188-1615
Reason for Recall
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.
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 in Commerce
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, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARAIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF KOREA, QATAR, PROTUGAL, POLAND, PHILIPPINES, PERU, OMAN, NORWAY, MEXICO, MALAYSIA, LITHUANIA, LEBANON, KOSOVO, KENYA, KAZAKHSTAN, JAPAN, JAMAICA, ITALY, ONDONESIA, INDIA, HUNGRY, HONG KONG, GUATEMALA, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, and ALGERIA.
Whoops. So let me get this straight. The probe which might be used to scan breasts, testes, and other important parts might burn them? Ouch! I'm keeping my small parts away from this particular device for the foreseeable future. Check your serial number against the table published on the FDA page.
I suppose users could double-charge for thermography as well as sonongraphy...