FDAFDA · Food and drugs·Recall number Z-0812-2025
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
Published January 15, 2025 · Recall initiated: November 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Medical Systems, LLC
- Distributor
- Worldwide
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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