{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Waukesha", "address_1": "3000 N Grandview Blvd", "reason_for_recall": "GE Healthcare has become aware of a potential safety issue due to the S4-10-D Ultrasound Probe used in conjunction with the LOGIQ S8 and LOGIQ S7 Ultrasound systems. It was also discovered that this issue also leads to a specification issue of the acoustic output of this probe. There is a potential for a skin burn when the flow model in the cardiac application is activated with the S4-10-D Ultraso", "address_2": "", "product_quantity": "2061", "code_info": "Mfg Lot or Serial # 176132SU9 176138SU6 178028SU7 158247SU7 172656SU1 187599SU6 201614SU5 201615SU2 195234SU0 195237SU3 161686SU1 203123SU5 170272SU9 189160SU5 189162SU1 170273SU7 185619SU4 176924SU9 191894SU5 159964SU6 159768SU1 170197SU8 158248SU5 171540SU8 171541SU6 160741SU5 160742SU3 160743SU1 159766SU5 197761SU0 198949SU0 195241SU5 189928SU5 164268SU5 159963SU8 185116SU1 195242SU3 201967SU7 166218SU8 185968SU5 189165SU4 189166SU2 189167SU0 189168SU8 189169SU6 195235SU7 195236SU5 171371SU8 168779SU7 189163SU9 190393SU9 159767SU3 167274SU0 201464SU5 195233SU2 171369SU2 177085SU8 186501SU3 171370SU0 187022SU9 191063SU7 185969SU3 168788SU8 159965SU3 201612SU9 159604SU8 178592SU2 178593SU0 178594SU8 178595SU5 185620SU2 185621SU0 176926SU4 176925SU6 191893SU7 177084SU1 192952SU0 195238SU1 195239SU9 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199499SU5 199500SU0 199501SU8 199502SU6 199503SU4 199504SU2 199505SU9 199506SU7 199607SU3 199608SU1 199609SU9 199610SU7 199611SU5 199612SU3 199616SU4 199617SU2 199618SU0 199619SU8 199620SU6 200174SU1 200345SU7 201216SU9 201217SU7 201218SU5 201219SU3 201220SU1 201221SU9 201222SU7 201223SU5 201224SU3 201224SU3 201225SU0 201227SU6 201228SU4 201229SU2 201230SU0 201231SU8 201232SU6 201233SU4 201440SU5 201445SU4 201447SU0 201448SU8 201449SU6 201450SU4 201451SU2 201452SU0 201453SU8 201454SU6 201455SU3 201456SU1 201457SU9 201458SU7 201459SU5 201460SU3 201461SU1 201462SU9 201463SU7 201962SU8 201963SU6 201964SU4 201970SU1 202047SU7 202724SU1 203044SU3 203045SU0 203124SU3 203279SU5 203313SU2 203339SU7 203448SU6 203449SU4 203451SU0 203452SU8 203453SU6 203457SU7 203460SU1 203617SU6 203712SU5 203718SU2 203719SU0 203720SU8 203721SU6 203722SU4 203723SU2 203724SU0 203887SU5 203888SU3 203889SU1 203890SU9 203891SU7 203892SU5 203893SU3 203894SU1 203895SU8 203896SU6 203899SU0 203900SU6 203902SU2 203903SU0 203904SU8 203905SU5 203907SU1 203908SU9 203910SU5 203911SU3 203912SU1 203913SU9 203914SU7 203985SU7 203986SU5 204250SU5 204252SU1 204253SU9 204254SU7 204255SU4 204256SU2 204257SU0 204258SU8 204259SU6 204260SU4 204261SU2 204262SU0 204263SU8 204264SU6 204269SU5 204270SU3 204271SU1 204272SU9 204273SU7 204274SU5 204572SU2 204573SU0 204574SU8 204575SU5 204576SU3 204577SU1 204578SU9 204579SU7 204580SU5 204581SU3 204582SU1 204583SU9 204584SU7 204585SU4 204586SU2 204587SU0 204588SU8 204726SU4 204727SU2 204906SU2 204907SU0 204908SU8 204909SU6 204910SU4 204911SU2 204912SU0 204913SU8 204914SU6 204915SU3 204916SU1 204917SU9 204918SU7 204919SU5 204920SU3 204926SU0 204927SU8 205520SU0 205521SU8 205522SU6 205523SU4 205524SU2 205525SU9 205526SU7 205527SU5 205548SU1 205549SU9 205550SU7 205551SU5 205552SU3 205553SU1 205554SU9", "center_classification_date": "20130411", "distribution_pattern": "Worldwide Distribution, USA, including the states of AL, AZ, AR, CA, CO,K CT, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT NE, NV N NJ, NM, NY, NC, ND, OH, OK, PA, RI ,SC, SD, TN, TX, VA, WA, WI and the countries of AUSTRALIA, AUSTRIA, BRAZIL, CANDA, CHILE, CHINA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY INDIA, INDONESIA ITALY JAPAN, KOREA, LATVIA, LEBANON, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA , SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM.", "state": "WI", "product_description": "GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation.", "report_date": "20130417", "classification": "Class II", "openfda": {}, "recalling_firm": "GE Healthcare, LLC", "recall_number": "Z-1096-2013", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "64725", "termination_date": "20131121", "more_code_info": "", "recall_initiation_date": "20130208", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }