GE Medical Systems, LLC Recall 95958
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
GE Medical Systems, LLC Recall 95958 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0812-2025 |
| Event ID | 95958 |
| Event 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 Type | Devices |
| Distribution | Worldwide |
| Quantity | 281 units |
| Recall Reason | 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. |
| Device Classification | 20250115 |
| Device 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. |
| Center Classification Date | 20250107 |
| Recall Initiation Date | 20241125 |
| Recalling Firm | GE Medical Systems, LLC |
| Initial Notification | Letter |
| Similar To |