{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95958",
      "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",
      "recall_number": "Z-0812-2025",
      "product_description": "GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers:    1) 5555000-12;   2) 5555000-5;   3) 5555000-6;   4) A0659PB;   5) to be provided",
      "product_quantity": "281 units",
      "reason_for_recall": "GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.",
      "recall_initiation_date": "20241125",
      "center_classification_date": "20250107",
      "report_date": "20250115",
      "code_info": "1) 5555000-12:  UDI/DI none, Serial Numbers:  082407100532; UDI/DI to be provided, Serial Numbers:  082407160512;   2) 5555000-5:  UDI/DI 840682115261, Serial Numbers:  1557XR0205, 352867XRA, 478765CDP1, 509962KV220, 601358OPTX220, 620421P3, 813872OPT3, SB2201700099WK; UDI/DI  none, Serial Numbers:  479314220, 00028MOB12, 203694SB3, 205820DP1, 208666KDM, 209334OPT1, 210703M3, 240566PX2, 240964OPT1, 248465DP3, 256HHPORT2, 256HHPORT3, 256MHPORT1, 281MSL220, 281MSL2202, 305KEN220A, 306766DMOB2, 310680PORTDR2, 314251NAV7, 325574OPTITBD2, 330489DIGPORT, 333OPTI2, 333OPTI3, 333OPTI4, 352596OPT1, 352LEEDP1, 352VILDP1, 386FHODP3, 401OPTI1, 405636P2, 405636P240, 405752OPT1, 405752OPT2, 405752OPT4, 405DELCITY220, 407303OPTIMAX220, 408259AP6, 417347DPORT1, 417556P1, 417556P2, 417556P3, 419251DP1, 419251DP2, 419383DP1, 434654OPTIMA, 435CVXR220, 480MAYO220A, 501364OPTI1, 501364OPTI2, 509474DR1, 510437OPT1, 510727OPT3, 512SAMCSB, 513870DP1, 520TMCOPT2, 541426XR220, 559447OPT1, 559784OPT2, 561694OPT1, 561694OPT2, 561965DPORT5, 561965DPORT7, 573882DP1, 573882DP2, 573882DP3, 580421OPT1, 601288SB1, 601288SB2, 601288SB3, 601288SB6, 601928D220, 608364OPMX220, 613938XR3, 626457GEPORT1, 703369MDIG2, 703664M7, 706596SFP2, 706651DP, 715838DP2, 718206OPT240C, 718267DP5, 718670PTDR1, 720UCHSB7, 727848SB1, 731541SB1, 731541SB1A, 731541SB2, 731541SB3, 732324PA1, 732828DP11, 757388DP4, 770385220D1, 772468OPT1, 785776AMX220P1, 804281SMDM1, 806296OPTI220, 813302OPT3, 814837OPT, 815300M220C, 817927JPSXR220G, 817MCAXR220B, 828213DXP1, 828262P2202, 830RHHM1, 830RHHM2, 843847220B, 850325DP2, 863699OP220, 903886XR220, 905527XR220, 905845MOB4, 908685DP2, 909464220P1, 910615OPTIMA1, 910615OPTIMA2, 915521OPTIMA1, 915595OPT1, 940898XR220A, 940898XR240D, 985867M1, AXXXXX38, ORMCPORTA, ORMCPORTB, ORMCPORTC, ORMCPORTD, TAMXDRP03, WD0005, XR1036454WK5;   3) 5555000-6:  UDI/DI 840682115261, Serial Numbers:  06051MOB06, 228809XR220, 228818XR220, 270798XR220B, 281KINGOPT3, 303450SB3, 303695SB3, 416323MOB3, 530888OPT1, 540981ODP3R, 540981ODP9, 615769OPTX220, 713529MDR220, 717782OPT4, 7982XR0192, 802775SB1, 813681OPT2, 918307OPT2, MHSWOPT2201, SA2513MM03, SB2201600071WK, SB2201700085WK, SJRO220P1, SJRO220P3, UTAHJAZZ, XR1864CO; UDI/DI none, Serial Numbers:  083007001584712, 0850070865, 0850070866, 0850070870, 0850070913, 0856070254, 0856070267, 0856070268, 091026DEMO2245, 10181MOB16, 140024RX14, 206598USB7, 209943OTP1, 214PH220G, 228575D220, 254HHSMOB1, 256429PORT2, 270688SB5, 281338BAPOR1, 281338CL221, 281338MDR220, 281348KWDM2, 281348KWDM3, 281KINGOPT1, 281MWB2202, 281MWB2203, 304255OPT220, 304623OPT220, 308865GSDP1, 309779RDIG2, 314525NAV15, 314525NAV16, 318675PW1, 318675PW2, 318769RDPT1, 318769RDPT2, 330480DP1, 330480DP2, 330480DP3, 330480DP4, 370OPTI1, 409938DR1220, 412232DMX2, 412372DMX1, 412647DMX2, 419291DP4, 419893DP1, 423493DP2, 432685OPT2, 434799GE220, 469764XR220H, 504454XR221, 504785MD1, 504873TMD8, 513732DP1, 563742NDIG1, 574267XR220, 586263DP1, 586493DP1, 601798D220, 614257DP4, 615284STMDR2, 615284STMDR3, 615316DP1, 615342DP1, 615391SUR, 702SIEXR221, 702SIEXR226, 713359BSDM3, 713440DP1, 713441OPCDX1, 714966GEPORT2, 720UCHSB9, 740592OPTIMA2, 77522MOB14, 801479SB2, 810342DP2, 817255NHXR220A, 817HUG220C, 817PLAZA220A, 817SAGERXR220A, 865541DP2, 865545DP1, 865545DP3, 903CSM222, 904OPMCDP3, 914737PORTWK3, 915577XR220, 916UCDAMXDR23, 916UCDAMXDR27, 918579OPT2, 919774DIGPRT, 928757XR222, 936539DM1, 936539DM2, 949517DR1, 949764DR2, 949764DR3, 949764DR4, 972420XR220B, 972420XR220C, 972566XR220F, 979MGXR220, LLPM220P1, MHKOPT220, SA1056MM06, SA2161MM04, XR1031657WK8, ZA1067RX30;   4) A0659PB:   UDI/DI 840682115261, Serial Numbers:  702880EROP1; UDI/DI none, Serial Numbers:  206598USB6;   5) to be provided:  UDI/DI none, Serial Numbers:  240826OPT1, 772SRDP1, 817HUG220B 860545SB2A; UDI/DI to be provided, Serial Numbers:  907852OPT22019, SA1075MM04.",
      "more_code_info": ""
    }
  ]
}