GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.

No consignee letter was sent out. Starting on July 13, 2012, Field Engineers visited consignees and carried on instructions as per Field Modification Instruction (FMI 79044A). The Engineer returned the system to the customer and ensure acceptance. Before leaving the customer site have the staff operate the system. Ensure that: all settings are customized, all peripherals are functioning and all communications are working properly. We plan to update the software on all of the affected GE VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM that were distributed. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. Further questions please call 262-513-4122.