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.
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. Distribution: Worldwide Quantity: 281 units Lot/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, 817MCAX
082407100532, 082407160512, 840682115261
Official record: FDA (Device enforcement) ↗
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