Recall Z-1833-2013 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
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 pediat
| Date | Jul 31, 2013 (initiated Jul 13, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 effectiven |
| Quantity | 375 |
| Distribution | Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRIL, CANADA, CHINA, COLOMBIA, DENMARK, EGYPT, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112213 | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare, Sep 1, 2011 |