GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1…

Date posted by the FDA

Jan. 11, 2012

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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 prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Reason

GE 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

Distribution pattern

Worldwide 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, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, NETHERLANDS, NEW ZEALAND, NORWAY, PANAMA, PHILIPPINES, PORTUGAL, REPUBLIC OF KOREA, ROMANIA, RUSSIAN FEDERATION,SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN,SWEDEN, SWITZERLAND, TAIWAN, and UNITED KINGDOM..

Quantity

894

Codes and lots

Serial Number 103674US8 105837US9 104914US7 104936US0 105527US6 104692US9 102751US5 104924US6 103932US0 100901US8 100461US3 104253US0 104257US1 105521US9 104943US6 104252US2 104941US0 98527US5 106276US9 106324US7 104669US7 104217US5 106966US5 105488US1 96282US9 106381US7 105373US5 100021US5 106341US1 105068US1 104909US7 104956US8 104933US7 106512US7 103928US8 106450US0 106380US9 105704US1 106571US3 106570US5 106574US7 105222US4 106378US3 100434US0 100443US1 102760US6 105827US0 105519US3 106379US1 103908US0 102853US9 103458US6 94284US7 102454US6 97788US4 105740US5 105128US3 103810US8 100304US5 103395US0 96382US7 95471US9 105744US7 99804US7 104366US0 106563US0 103820US7 105329US7 105350US3 105339US6 95985US8 95965US0 95961US9 105461US8 107078US8 107154US7 103741US5 104776US0 107075US4 107079US6 106180US3 105608US4 106958US2 106843US6 106954US1 106977US2 105469US1 106846US9 107026US7 107110US9 107137US2 102952US9 96866US9 99107US5 99104US2 96812US3 106946US7 106472US4 105278US6 107044US0 107086US1 106829US5 107061US4 107035US8 107152US1 107196US8 107030US9 107096US0 107133US1 96791US9 107124US0 107010US1 106908US7 104889US1 107192US7 107117US4 100084US3 106405US4 94348US0 103772US0 106730US5 96232US4 96173US0 102281US3 105948US4 105940US1 104938US6 102276US3 106771US9 99287US5 103768US8 100297US1 97785US0 106302US3 105691US0 106294US2 104086US4 106776US8 104797US6 105362US8 106535US8 104198US7 104877US6 105721US5 105850US2 104278US7 104616US8 104831US3 106839US4 104875US0 105760US3 105122US6 106853US5 106851US9 104817US2 97344US6 98846US9 94943US8 98739US6 103697US9 105124US2 106815US4 105736US3 105931US0 106810US5 106629US9 105670US4 103028US7 94125US2 105076US4 102183US1 99937US5 98975US6 102918US0 103923US9 105231US5 105223US2 104828US9 106484US9 105150US7 106090US4 106956US6 106168US8 106803US0 100984US4 105617US5 95409US9 103086US5 105123US4 106035US9 106715US6 106757US8 100362US3 100369US8 102728US3 103895US9 105415US4 97263US8 106568US9 102591US5 106824US6 96607US7 106669US5 106818US8 95665US6 105393US3 105490US7 97209US1 100946US3 105282US8 104307US4 106667US9 105680US3 105976US5 105116US8 105141US6 105576US3 105565US6 104282US9 105573US0 105432US9 106799US0 105382US6 106627US3 101665US8 106666US1 103093US1 105385US9 100452US2 103662US3 99060US6 103792US8 105616US7 95197US0 95131US9 104426US2 104203US5 103971US8 105860US1 106982US2 106968US1 103668US0 103637US5 103642US5 106234US8 105614US2 100897US8 107004US4 105719US9 105672US0 106980US6 99159US6 101537US9 101530US4 105874US2 105902US1 105623US3 105889US0 104091US4 103633US4 100490US2 104354US6 105893US2 99284US2 106494US8 105682US9 99663US7 104564US0 102013US0 99007US7 97914US6 106903US8 107051US5 105601US9 99080US4 103854US6 107206US5 104854US5 104486US6 105730US6 103146US7 103875US1 101171US7 97917US9 103935US3 105830US4 105795US9 95729US0 99062US2 100829US1 98804US8 99641US3 104285US2 106872US5 106893US1 102799US4 101909US0 104858US6 104876US8 103016US2 105143US2 97740US5 96113US6…

Recall started

Jan. 3, 2012

Device type

System, Imaging, Pulsed Doppler, Ultrasonic

Root cause (FDA)

Software design

What the company told customers

The 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).

Recall number

Z-0705-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0705-2012. The agency record governs; check it and the company before acting.