Recall Z-1944-2013 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE Healthcare, LLC
GE Healthcare, LOGIQ S8 Ultrasound System 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 prostate); Transrectal; Transvaginal and Intraoper
| Date | Aug 9, 2013 (initiated Aug 13, 2012) |
| Status | Terminated |
| Reason | GE Healthcare became aware of a potential issue related to incorrect image measurement associated with the software of the LOGIQ S8 system. This issue was found internally. Users may notice that the system shows incorrect image measurement results on Pulsed Wave (PW) or Time Intensity Curve (TIC) or depth measurement when using Virtual Convex mode and putting a cursor (Sample Volume, Depth measur |
| Root cause | Software design |
| Action | GE initiated a field action on 8/13/12. GE plans to update the software on all of the affected GE LOGIQ S8 Ultrasound systems that were distributed, at no cost to the customer. Should you have any questions or require additional information, please contact RA Leader, US Region by telephone at 262-548-2089 or email James.Giles@med.ge.com. |
| Quantity | 755 |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, DC, FL, GA, IL, IN, IA, LA, MA, MI, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, PA,RI, SC, TN, TX, VA, WA, and WI; and countries of: ALGERIA, AUSTRALIA, AUSTRIA, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, DENMARK, ESTONIA, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111582 | LOGIQ S8 GE Healthcare, Jul 26, 2011 |