{"recall":{"id":"fda-device-99279","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"GE Medical Systems, LLC recalls 3 products","firm":"GE Medical Systems, LLC","date":"2026-06-05","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Optima XR200amx, Mobile Digital-Ready Radiographic System","code":"UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100","quantity":"4 units","number":"Z-2726-2026","classification":"Class II"},{"name":"Optima XR220amx, Mobile Digital-Ready Radiographic System","code":"UDI-DI: 00840682115261; System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SBOPT1, 314251P5, 352LEEDP1, 386FLGDPXR3, 417347DPORT1, 512SAMCSB, 516632OPTIMA2, 540981ODP7, 563264OPT, 601445DP1, 615338HDP01, 661949DP2, 713441OPCDX1, 717657OPT1, 718206OPT240A, 727848SB1, 732321DP1, 757736DP3, 813302OPT1, 828213DXP1, 828286OPT1, 843847220D, 850070941, 865545DP3, 915821OPT1, 941342OP221, 972566XR220E, 985447TM4, SA1208MM05, SB2201700085WK, XR1034798WK7, XR1037005WK4","quantity":"38 units","number":"Z-2727-2026","classification":"Class II"},{"name":"Optima XR240amx, Mobile Digital Radiographic System","code":"UDI-DI: 00840682122351 and 00840682123686; System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM13","quantity":"24 units","number":"Z-2728-2026","classification":"Class II"}],"reason":"GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.","nationwide":true,"states":[],"units":"4 units; 38 units; 24 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99279","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"24601a4d39ec1e6b","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99279","record":[{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99279","recalling_firm":"GE Medical Systems, LLC","address_1":"3000 N Grandview Blvd","address_2":"","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.","recall_number":"Z-2726-2026","product_description":"Optima XR200amx, Mobile Digital-Ready Radiographic System","product_quantity":"4 units","reason_for_recall":"GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.","recall_initiation_date":"20260605","center_classification_date":"20260713","report_date":"20260722","code_info":"UDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100","more_code_info":""},{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99279","recalling_firm":"GE Medical Systems, LLC","address_1":"3000 N Grandview Blvd","address_2":"","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.","recall_number":"Z-2727-2026","product_description":"Optima XR220amx, Mobile Digital-Ready Radiographic System","product_quantity":"38 units","reason_for_recall":"GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.","recall_initiation_date":"20260605","center_classification_date":"20260713","report_date":"20260722","code_info":"UDI-DI: 00840682115261; System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SBOPT1, 314251P5, 352LEEDP1, 386FLGDPXR3, 417347DPORT1, 512SAMCSB, 516632OPTIMA2, 540981ODP7, 563264OPT, 601445DP1, 615338HDP01, 661949DP2, 713441OPCDX1, 717657OPT1, 718206OPT240A, 727848SB1, 732321DP1, 757736DP3, 813302OPT1, 828213DXP1, 828286OPT1, 843847220D, 850070941, 865545DP3, 915821OPT1, 941342OP221, 972566XR220E, 985447TM4, SA1208MM05, SB2201700085WK, XR1034798WK7, XR1037005WK4","more_code_info":""},{"status":"Ongoing","city":"Waukesha","state":"WI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99279","recalling_firm":"GE Medical Systems, LLC","address_1":"3000 N Grandview Blvd","address_2":"","postal_code":"53188-1615","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.","recall_number":"Z-2728-2026","product_description":"Optima XR240amx, Mobile Digital Radiographic System","product_quantity":"24 units","reason_for_recall":"GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.","recall_initiation_date":"20260605","center_classification_date":"20260713","report_date":"20260722","code_info":"UDI-DI: 00840682122351 and 00840682123686; System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM13","more_code_info":""}]}}