GE Healthcare (China) Co., Ltd.: GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 22

Hazard

The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install.

Details from the source

Reason for recall: The XR system, Proteus XR/a, does not have a de-installation manual describing process steps for de-installing the devices. De-installation instruction process steps must be followed when de-installing these devices to avoid personnel injury during de-install. Distribution: Worldwide distribution. Quantity: 3572 units Lot/code info: 1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PRO; 2) 2259988: UDI/DI 00840682106139: System ID Numbers: 305682PROTEUS, 305MCPCPRO, 828262PROT, 631376ER2, 716675DPRO1, 206965XR; UDI/DI 00840682120777: System ID Numbers: 251435PROT, 334418PRO, 334418XRA, 520MERPRO, 805652DR2, 303320TPXR, 970248PROT, 203732PROT, 203876XRA564, 941792PROTEUS, 305CGHPROTEUS, 561495RAD1, 850837PROTEUS, 352FRIPRO, 386LCMCER1, 813344PROTXR, 561881ICRAD, 850469PROT, 561655XRA, FWR1453, 478289PRO, 847298AMGPROT, 630225NWMGE02PXRA, 630225NWMGEO1D, 630241PROT, 317439PROT, 317338SPORTS, 317773PROT, 317204PROT, 913491PROXR1, 620421PRO1, 785543PRO, 785743PRO, 598761NVP, 906483XRA564, 313745RERPROT, 1000001522, 601855PROTEUS, 662773RAD1, 662756PRO, 704323FA, 704323PROS, 908237RAD, 201656PROT, 575439PROT, 585227PRO1, 914964PROT, 740HVCHPRO, 740333PROT1, 740FAYPRO, 724547XR1, 864512KCPROT, 843681PROTEUS, 843839XR, 901767PROTXR, 737202PROT, SDNAMCTRAUMA, 281897XRPRO, 254751PROLL, 512SDMCLER, 254751XRA, 804TRIPRO, 804285PRO1, 804285PRO2, 540970ER, 360475PSNSPROT, 509674CEX1, 920907PROT1, 414529PRO1, 608785PROTBEL, 414385PRO1, 414978PRO, 414570PRO1, 920303PROT1, 262542PROXRA, 414479PRO4, 414607PROXR1, 905732RAD2, RU8366RX01, ZA2985RX01, 34442RAD01, XR1383UY; UDI/DI none: System ID Numers: 907842PROTX, 907796ORTHO, 907796PROT, 907443PROTEUS, 907861VER, 256235ORT1, 251368ARAD, 205481PRO, 205592DCPRO, 251847RAD, 205280PRO, 256737PRO, 251435R1, 25127

UPC codes

00840682120777, 00840682106139, 83093535827, 83109605126, 83094378263, 83089838806, 83091661241, 83135048766, 82407110020, 82407040101, 82407040216, 82407290043, 82407290040, 82407160217, 82407160198, 82407180030, 82407180040, 82407180033, 82407180026, 82407070068, 82407070120, 82407070064, 82407120062, 82407040378, 82407100342, 82407100182

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.