ClearanceBrief
Recall Z-0705-2012 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

GE Healthcare, LLC

GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. The device is intended for use by a qualified physician for ultrasound evaluation 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 prosta

DateJan 11, 2012 (initiated Jan 3, 2012)
StatusTerminated
ReasonGE Healthcare has recently become aware of a potential safety issue associated with the data of your LOGIQ E9 system that may impact patient safety. 1 - User may notice an image from a different patient, or an image from the current patient with title information from a different patient. 2 Incorrect measurements/calculations on images, when viewed on the off-line review station. As a re
Root causeSoftware design
ActionThe firm, GE Healthcare" sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 20, 2011 to its customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, Contact Information and actions to be taken. The customers were instructed to ensure that all potential users in their facility are made aware of this safety notification and recommended actions and to follow the safety instructions noted in the letter. If you have any questions or concerns, contact your local GEHC service representative at 1-800-321-7937 (USA/Canada).
Quantity894
DistributionWorldwide distribution: USA (nationwide) including states of: AK, AZ, ALR, CA, CO, CT, FL, GA, IL, IN, IA, LA, LME, MD, MA, MI, MN, MS, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TIN, TX, UT, VA, WA, WV, WI, and WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM CANADA, CHILE, CHINA, CROATIA
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K110943LOGIQ E9
GE Healthcare, Jul 22, 2011