Recall Z-1833-2013— GE Healthcare, LLC

Name: FDA recall Z-1833-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-13

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-07-13, terminated 2014-11-10. It names one FDA 510(k) clearance: K112213. Product: 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).. 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Terminated: 2014-11-10
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K112213 — VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEMGE Healthcare·cleared 2011-09-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.