FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
- Recall number
- Z-0813-2025
- Recalling firm
- GE Medical Systems, LLC
- Product
- GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8) To be provided.
- Status
- Open, Classified
- Initiated
- 2024-11-25
- Posted
- 2025-01-07
- Terminated
- not on file
- 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.
- Root cause
- Component design/selection
- Action
- GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 11/25/2024 via letter issued using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken by the user: "1. Perform a check of your device prior to each patient exam to look for the following behaviors. If any are observed, DO NOT use the device and call GE HealthCare Service Immediately. . Column vertical movement requires increased effort. . Column has change in resistance (i.e. movement is not smooth) during vertical movement. . Column makes abnormal noises during vertical movement. 2. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. 3. Please retain this document for your records. 4. Please complete and return the attached acknowledgement form to RECALL.10964@gehealthcare.com" For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative. On 02/11/2025, the firm send an updated notice with a corrected GTIN for Optima XR200amx.
- Quantity
- 120 units
- Distribution
- Worldwide
- Lot, serial or model codes
- 1) 5555000-27: UDI/DI 840682122351, Serial Numbers: 228867XR240, 252847PP241, 281274OPT1, 281338CL240, 281VHVXR240, 305682DIG1, 305682DIG3, 305KEN240B, 401OPTI2, 405949OPT1, 408559XRDR7, 413447OPT1, 419251OPT, 419690DP1, 504842XR242, 602344240A, 602344MARY240, 713440DP2, 713440DP3, 720854DF1, 732222DP3, 763520XR10, 763520XRA6, 806725OPT, 865305DP1, 941276XRA, 970495OPTI1, 973926OPT1, BOLDWPACPORT02, GLEDWPACPORT02, HMHWT240P5, LIHOPTIMA240B, OCHSNERWB240, SAMC240A; 2) 5555000-31: UDI/DI 840682122351, Serial Numbers: 00158MOB17, DF2401800221WK, U416249MOB240; 3) 5555000-33: UDI/DI 840682122351, Serial Numbers: 082407100689, 228867XR240C; 4) 5555000-41: UDI/DI 840682122351, Serial Numbers: 00130MOB16, 5973XR0225, DEF11034, RS4025RX05, SA1058MM50; 5) 5555000-47: UDI/DI 840682122351, Serial Numbers: 206223OPTIMA1, 206248OPT2, 206341OPT2402, 212838OPTIMA1, 219326AMX2, 256HHPORT5, 256HHPORT6, 260824XR240, 270793OPT, 270793OPT1, 304256OPTIMA240, 307324XR240, 318626OPX240FP, 336716WFP2, 336716WFP3, 404616OPT2, 405657OPT, 406345OPT1, 406653XR240, 406653XRA1, 414266XR243, 423837X240, 425228OPT240, 435713OPX240, 435789XR240, 502897M241, 504842OPTFP1, 504894XR244, 513952OPT1, 530888OPT2, 541789M3, 551996DIG1, 706527OPT2, 712662OPT240, 713440DP4, 718918XR240B, 785623OPT2, 786308XR240, 801465XR240, 805652M2, 816943XR240A, 828369OPT1, 850864FWDH240, 865977DP2, 901595XRA1, 914787XR2401, 916781OPT4, 951788XR240P2, 954723XR240B, 972596OPT3, 973877OPT1, AMX240GEN2SYSTEM17, AMX240GEN2SYSTEM9, HMHXR240P7, KAFB228OPTIMA2, LNMCDP1, LVCCER240B, MBMCPORTD; 6) A0700DL: UDI/DI 840682122351, Serial Numbers: 082407250223; 7) A1700DA: UDI/DI 840682122351, Serial Numbers: 210METM2, 256543OPT, 337261OPT, 360744OPT2402, 425899OPT, 425SNORIDGE, 509946AMX1, 573814DP8, 574231OPT2, 702852OPT, 850864FWDH2401, HMHXR240P1, OMCTOPT1; 8) To be provided: UDI/DI To be provided, Serial Numbers: 256543OPT1, 405657FP1417, 513952OPT2, RU1018RX04.
- 510(k) numbers
- ["K162990","K173602","K182234"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28