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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, LOGIQ e Ultrasound System.

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 Class 2 Device Recall GE Healthcare, LOGIQ e Ultrasound System. see related information
Date Posted August 01, 2013
Recall Status1 Terminated on September 15, 2014
Recall Number Z-1849-2013
Recall Event ID 65759
510(K)Number K113690 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product GE Healthcare, LOGIQ e Ultrasound System.

The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Code Information Mfg Lot or Serial #
223133WX0
223134WX8
223135WX5
223136WX3
223137WX1
224634WX6
224635WX3
224636WX1
224637WX9
224638WX7
224639WX5
224640WX3
224641WX1
224642WX9
224643WX7
224644WX5
224645WX2
224786WX4
224787WX2
224788WX0
224789WX8
224790WX6
224791WX4
224792WX2
224793WX0
224794WX8
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224796WX3
224797WX1
224798WX9
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224800WX3
224801WX1
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224803WX7
224804WX5
224805WX2
224806WX0
224807WX8
224808WX6
224951WX4
225010WX8
225011WX6
225012WX4
225013WX2
225014WX0
225015WX7
225143WX7
225144WX5
225145WX2
225146WX0
226933WX0
226934WX8
226935WX5
226936WX3
226937WX1
227218WX5
227219WX3
227221WX9
227222WX7
227223WX5
227224WX3
227225WX0
227226WX8
227227WX6
227228WX4
227229WX2
227230WX0
227231WX8
227232WX6
227233WX4
227279WX7
227280WX5
227281WX3
227282WX1
227283WX9
227284WX7
227285WX4
227286WX2
227287WX0
227288WX8
227574WX1
227575WX8
227576WX6
227577WX4
227578WX2
228256WX4
228257WX2
228258WX0
228259WX8
228260WX6
228772WX0
228773WX8
228774WX6
228775WX3
228776WX1
228777WX9
228778WX7
228779WX5
228780WX3
229786WX9
229787WX7
229790WX1
229791WX9
229792WX7
229793WX5
231677WX6
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231681WX8
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231690WX9
232467WX1
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232470WX5
232471WX3
232472WX1
232473WX9
232474WX7
232500WX9
232501WX7
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232504WX1
232505WX8
232506WX6
233383WX9
233384WX7
233385WX4
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233387WX0
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233390WX4
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235601WX2
235602WX0
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235605WX3
236395WX0
236396WX8
236397WX6
236398WX4
236399WX2
237120WX1
237121WX9
237122WX7
237123WX5
237124WX3
237617WX6
237618WX4
237619WX2
237620WX0
237621WX8
238640WX7
238641WX5
238642WX3
238643WX1
238644WX9
240405WX1
240406WX9
240407WX7
240408WX5
240409WX3
240410WX1
240411WX9
240412WX7
240413WX5
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240415WX0
240416WX8
242064WX4
242065WX1
242070WX1
242071WX9
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242075WX0
242076WX8
242077WX6
242078WX4
242499WX2
242500WX7
242501WX5
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242503WX1
242504WX9
242505WX6
242506WX4
242507WX2
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242510WX6
242511WX4
242512WX2
242513WX0
242514WX8
242515WX5
242516WX3
242517WX1
242518WX9
237748WX9
237749WX7
225460WX5
225461WX3
225462WX1
225463WX9
225464WX7
227289WX6
227290WX4
228781WX1
229268WX8
229269WX6
229272WX0
229938WX6
229939WX4
229940WX2
229941WX0
229988WX1
234511WX4
234512WX2
234513WX0
237717WX4
237718WX2
237719WX0
237720WX8
237721WX6
237722WX4
237723WX2
241117WX1
235655WX8
237114WX4
237116WX9
224959WX7
233265WX8
237747WX1
231964WX8
237119WX3
224958WX9
227137WX7
227855WX4
228803WX3
228804WX1
228805WX8
229156WX5
229157WX3
231967WX1
233263WX3
233316WX9
234462WX0
234463WX8
234464WX6
234465WX3
234617WX9
234925WX6
234927WX2
234928WX0
234930WX6
234931WX4
235656WX6
235665WX7
235666WX5
235667WX3
237102WX9
237112WX8
237113WX6
237742WX2
237752WX1
238517WX7
216340WX0
223130WX6
223131WX4
223132WX2
224955WX5
224956WX3
224960WX5
224989WX4
224990WX2
224991WX0
227856WX2
227857WX0
227859WX6
228807WX4
228811WX6
228812WX4
228879WX3
228880WX1
228881WX9
228883WX5
229152WX4
229153WX2
229154WX0
229155WX7
229159WX9
229160WX7
229161WX5
231962WX2
231966WX3
231969WX7
231970WX5
231973WX9
231974WX7
231975WX4
231976WX2
231977WX0
231978WX8
233261WX7
233314WX4
233320WX1
233322WX7
234468WX7
234469WX5
234471WX1
234472WX9
234613WX8
234614WX6
234615WX3
234616WX1
234618WX7
234921WX5
234926WX4
235600WX4
235658WX2
235660WX8
235661WX6
235662WX4
235663WX2
235668WX1
235891WX9
235892WX7
235893WX5
235894WX3
235895WX0
237096WX3
237097WX1
237099WX7
237110WX2
237115WX1
237118WX5
237739WX8
237743WX0
237744WX8
237745WX5
237746WX3
238519WX3
238520WX1
238521WX
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Image data from one patient has the potential to be linked to the patient ID of another patient.
FDA Determined
Cause 2
Software design
Action Starting on November 9, 2012, GE Healthcare, will plan to update the software on all of the affected GE LOGIQ e Ultrasound systems that were distributed at no cost to the customer. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. No Customer letter was sent. Further questions please call (262) 513-4122.
Quantity in Commerce 588
Distribution Worldwide Distribution - USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, DE, FL, GA, ID, IL , IA, MD, MA, MI, MS, MO, NJ, NM, NY, NC, OH, PA, RI, SC, TN,TX, UT,VT, VA and WI., and the countries of ARAB EMIRATES, AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, INDIA, ITALY, JAPAN, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND and UNITED EMIRATES.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = GE HEALTHCARE
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