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U.S. Department of Health and Human Services

Class 2 Device Recall LOGIQ S8 Ultrasound System

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 Class 2 Recall
LOGIQ S8 Ultrasound System
see related information
Date Posted August 09, 2013
Recall Status1 Terminated on September 15, 2014
Recall Number Z-1944-2013
Recall Event ID 65583
Premarket Notification
510(K) Number
K111582 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product 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 Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Code Information Mfg Lot or Serial # 171947SU5 176566SU8 176567SU6 179458SU5 182385SU5 182653SU6 182654SU4 182656SU9 164236SU2 173818SU6 172242SU0 172243SU8 176260SU8 180632SU2 181231SU2 181232SU0 181233SU8 181234SU6 181235SU3 158763SU3 158799SU7 159780SU6 163222SU3 165600SU8 168075SU0 169495SU9 170681SU1 170893SU2 171937SU6 171941SU8 171943SU4 176123SU8 176125SU3 176129SU5 177080SU9 178951SU0 180108SU3 180110SU9 180763SU5 180766SU8 182661SU9 182379SU8 176132SU9 159604SU8 159766SU5 158247SU7 172656SU1 161686SU1 170273SU7 170272SU9 170274SU5 176924SU9 159768SU1 170197SU8 171541SU6 171540SU8 171542SU4 164268SU5 166218SU8 171371SU8 168779SU7 167274SU0 171369SU2 177085SU8 177084SU1 171370SU0 168788SU8 178593SU0 178594SU8 178595SU5 176926SU4 176925SU6 158248SU5 159963SU8 160741SU5 160742SU3 160743SU1 159964SU6 178592SU2 159965SU3 159767SU3 181434SU2 166181SU8 183107SU2 169509SU7 159792SU1 183118SU9 170672SU0 176130SU3 182380SU6 158768SU2 159776SU4 182223SU8 182222SU0 183104SU9 166172SU7 170671SU2 168080SU0 182655SU1 183102SU3 183907SU5 176939SU7 180973SU0 176938SU9 183660SU0 183661SU8 180363SU4 159246SU8 158802SU9 158805SU2 180762SU7 170669SU6 170679SU5 170683SU7 162595SU3 162592SU0 170670SU4 183108SU0 168064SU4 169487SU6 169506SU3 176121SU2 158806SU0 178022SU0 159784SU8 165587SU7 168058SU6 170676SU1 163224SU9 159789SU7 182227SU9 178023SU8 165585SU1 168056SU0 182228SU7 182376SU4 168063SU6 183105SU6 168068SU5 170675SU3 168069SU3 165588SU5 175622SU0 175623SU8 168070SU1 180761SU9 182382SU2 176136SU0 159782SU2 159783SU0 168057SU8 182230SU3 183106SU4 182378SU0 168060SU2 163225SU6 183109SU8 183110SU6 168059SU4 166185SU9 159788SU9 178018SU8 170674SU6 161687SU9 161688SU7 161689SU5 161690SU3 161691SU1 161692SU9 162593SU8 162594SU6 165584SU4 176135SU2 165583SU6 165586SU9 182377SU2 158800SU3 159793SU9 159951SU3 168074SU3 170892SU4 171944SU2 162596SU1 168071SU9 175624SU6 178027SU9 181605SU7 166178SU4 183120SU5 178026SU1 171946SU7 182224SU6 170897SU3 168073SU5 178016SU2 169502SU2 169508SU9 178029SU5 180768SU4 161694SU5 176138SU6 159249SU2 183116SU3 163230SU6 163223SU1 158759SU1 158766SU6 175617SU0 166176SU8 166177SU6 166174SU3 168055SU2 170673SU8 166180SU0 159247SU6 183113SU0 183114SU8 183115SU5 159777SU2 168838SU1 170898SU1 158767SU4 159779SU8 159778SU0 169511SU3 178038SU6 166183SU4 182221SU2 168072SU7 159781SU4 169505SU5 176128SU7 159785SU5 159786SU3 178019SU6 178020SU4 162597SU9 169493SU4 178017SU0 162599SU5 178028SU7 169510SU5 171945SU9 169513SU9 178025SU3 169503SU0 176131SU1 169504SU8 183888SU7 166179SU2 163229SU8 163231SU4 180765SU0 159775SU6 162598SU7 181433SU4 159774SU9 166175SU0 182226SU1 172890SU6 176015SU6 183119SU7 161695SU2 158764SU1 160740SU7 179387SU6 179388SU4 161696SU0 158808SU6 170894SU0 170896SU5 181432SU6 158760SU9 165598SU4 176013SU1 158807SU8 159248SU4 159244SU3 165599SU2 159251SU8 183112SU2 181431SU8 182381SU4 176122SU0 165590SU1 165589SU3 169501SU4 178021SU2 176127SU9 165591SU9 165592SU7 165593SU5 165594SU3 170895SU7 171942SU6 175618SU8 168053SU7 166279SU0 153258SU9 167283SU1 181309SU6 174785SU6 180006SU9 175346SU6 164232SU1 172855SU9 176440SU6 166275SU8 175348SU2 167282SU3 176445SU5 164237SU0 180365SU9 180005SU1 181311SU2 181308SU8 176444SU8 166282SU4 168782SU1 176443SU0 176447SU1 164238SU8 175349SU0 176441SU4 167285SU6 164233SU9 175347SU4 182435SU8 175350SU8 166280SU8 181312SU0 180000SU2 180366SU7 159608SU9 166276SU6 168787SU0 166278SU2 168786SU2 174784SU9 164239SU6 164240SU4 166274SU1 174781SU5 167277SU3 168783SU9 181314SU6 167284SU9 164235SU4 168781SU3 167286SU4 164234SU7 183468SU8 180004SU4 171934SU3 178952SU8 171933SU5 171931SU9 167278SU1 178954SU4 166281SU6 174782SU3 168780SU5 174783SU1 176442SU2 158244SU4 167279SU9 176446SU3 183469SU6 167280SU7 178953SU6 182388SU9 180367SU5 182384SU8 159952SU1 171936SU8 172853SU4 172854SU2 173816SU0 173817SU8 182436SU6 179999SU8 166283SU2 167281SU5 168784SU7 171932SU7 171935SU0 173819SU4 180001SU0 180002SU8 180003SU6 181310SU4 181313SU8 182233SU7 182234SU5 182235SU2 182386SU3 182387SU1 158243SU6 164241SU2 168785SU4 180364SU2 166277SU4 159241SU9 159956SU2 159601SU4 162830SU4 162832SU0 159605SU5 159598SU2 158245SU1 159597SU4 159599SU0 159602SU2 159606SU3 159607SU1 159947SU1 159948SU9 159949SU7 159950SU5 159953SU9 159954SU7 159955SU4 159957SU0 159958SU8 159959SU6 159960SU4 159961SU2 159962SU0 162831SU2 162833SU8 162834SU6 153254SU8 153255SU5 153256SU3 153257SU1 153260SU5 153259SU7 159596SU6 159600SU6 159603SU0 159242SU7 168065SU1 168066SU9 183103SU1 167276SU5 170347SU9 160385SU1 182236SU0 176017SU2 165582SU8 171948SU3 180773SU4 180774SU2 168319SU2 180772SU6 170666SU2 170668SU8 170667SU0 179252SU2 180771SU8 166184SU2 182374SU9 181425SU0 176133SU7 182229SU5 170677SU9 176139SU4 178030SU3 158761SU7 176141SU0 169512SU1 162600SU1 159243SU5 176126SU1 182225SU3 171938SU4 166173SU5 183111SU4 161693SU7 159250SU0 170680SU3 176124SU6 176016SU4 176014SU9 167275SU7 158259SU2 159240SU1 170198SU6 170271SU1 159245SU0 165595SU0 176134SU5 169507SU1 158246SU9 160531SU0 160530SU2 167648SU5 176887SU8 168521SU3 179997SU2 179023SU7 171032SU6 179998SU0 169486SU8 183101SU5 171033SU4 168778SU9 171255SU3 179324SU9 179325SU6 179326SU4 181430SU0 159787SU1 158765SU8 170682SU9 171939SU2 169491SU8 180764SU3 169492SU6 169490SU0 158801SU1 165597SU6 163227SU2 170678SU7 169489SU2 178024SU6 158762SU5 166182SU6 183117SU1 168067SU7 169488SU4 165581SU0 178031SU1 163226SU4 168054SU5 158803SU7 172241SU2 172240SU4 168854SU8 168855SU5 179272SU0 168079SU2 168077SU6 168078SU4 168076SU8 165596SU8 180767SU6 182375SU6 163228SU0 171940SU0 159252SU6 169500SU6 176142SU8 176143SU6 166186SU7 169494SU2 169496SU7 169497SU5 158804SU5 159790SU5 159791SU3 169498SU3 169499SU1 176008SU1 176009SU9 176010SU7 176011SU5 176012SU3 176140SU2 168061SU0 168062SU8 182383SU0 181427SU6 176137SU8 176145SU1 176146SU9 178014SU7 176119SU6 176120SU4 178015SU4 176118SU8 176144SU4 175619SU6 175620SU4 175621SU2 181428SU4 181429SU2 181426SU8 164267SU7 172653SU8 173362SU5 173364SU1 179457SU7 179456SU9 160126SU9 182659SU3 182660SU1 171022SU7 171031SU8 159772SU3 168692SU2 159133SU8 158236SU0 165746SU9 166466SU3 165747SU7 159773SU1 169348SU0 158237SU8 165741SU0 181642SU0 159771SU5 165745SU1 181643SU8 169788SU7 165329SU4 178009SU7 165738SU6 165742SU8 165576SU0 165579SU4 165749SU3 181644SU6 182437SU4 169784SU6 158239SU4 164379SU0 164381SU6 182440SU8 180109SU1 176004SU0 169346SU4 173822SU8 173823SU6 169785SU3 165748SU5 171030SU0 165739SU4 164265SU1 164380SU8 159134SU6 169780SU4 181645SU3 176005SU7 179455SU1 160528SU6 179452SU8 181641SU2 177276SU3 169781SU2 159254SU2 176007SU3 164377SU4 169782SU0 169343SU1 165325SU2 165326SU0 165327SU8 165332SU8 180107SU5 158235SU2 160529SU4 165744SU4 168691SU4 159770SU7 182662SU7 165577SU8 171024SU3 166468SU9 173363SU3 159769SU9 169345SU6 169344SU9 169347SU2 171023SU5 159257SU5 173821SU0 169777SU0 169787SU9 182441SU6 177277SU1 164378SU2 177081SU7 175345SU8 175344SU1 178008SU9 171027SU6 171029SU2 172651SU2 182658SU5 177275SU5 158238SU6 177083SU3 166467SU1 172649SU6 182442SU4 164264SU4 165323SU7 165324SU5 164263SU6 164266SU9 160128SU5 159253SU4 166465SU5 169778SU8 169786SU1 171028SU4 182438SU2 182439SU0 175342SU5 182657SU7 172648SU8 172650SU4 178007SU1 165328SU6 165330SU2 171025SU0 171021SU9 165740SU2 176006SU5 165578SU6 177082SU5 179454SU4 180106SU7 169783SU8 172652SU0 180105SU9 175343SU3 172654SU6 173365SU8 165743SU6 179453SU6 172655SU3 181646SU1 166464SU8 173820SU2 160527SU8 177278SU9 159255SU9 158240SU2 158241SU0 158242SU8 159132SU0 159135SU3 159256SU7 160127SU7 160129SU3 160130SU1 178006SU3 165331SU0 165333SU6 169779SU6 171026SU8 165580SU2 162601SU9
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
DESIGN: 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 in Commerce 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, FINLAND, FRANCE, GERMANY, GREECE, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, LATVIA, LEBANON, MALAYSIA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, REPUBLIC OF MOLDOVIA, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and YUGOSLAVIA.
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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