CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System recalled
GE Medical Systems is recalling GE Healthcare Optima XR220amx, Mobile Digital Radiographic System. The recall was initiated on 25 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0812-2025
- FDA event ID
- 95958
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Nov 2024
- FDA classified
- 7 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 25 Nov 2024 | Recall initiated by company | |
| 7 Jan 2025 | Classified by FDA | +43 days |
| 15 Jan 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95958| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GE Healthcare Optima XR200amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | WI | |
| CLASS II | GE Healthcare Optima XR240amx, Mobile Digital Radiographic System recalled | GE Medical Systems | Device Malfunction | WI |
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|---|---|---|---|---|---|
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