—#211642

Product

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103476, K142383
Affected lot / code info: 1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2; UDI/DI none, Serial Numbers: 10523MOB01, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 316858AMX200P1, 401OPTI3, 410368WP1, 443643WP1, 503251XR200, 512SDMCP1, 518243OPT2, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1, 661949DP2, 718630OPTIMAX, 760379DP, 801299SB1, 804417OPTIMA, 812237P1, 813745OPT1, 856355OPT, 904244MP1, 904244MP2, 904276DP200, 918477OPT1, 956365OPT1, 956632OPT2, 956632OPT4, XR1037005WK4; 2) 5555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1; UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100; 3) A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO.

Why it was 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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2024-11-25
Posted by FDA: 2025-01-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211642. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.