GE Healthcare (China) Co., Ltd.: GE Proteus XR/A radiographic system

Hazard

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

Details from the source

Reason for recall: Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List. Distribution: Worldwide - US Nationwide distribution. Quantity: 956 systems Lot/code info: UDI-DI: 00840682120777; System ID: 907443PROTEUS 251847RAD 256737PRO 251435PROT 251275RAD 251275RAD2 256486XR1 256429CR2 334732PXRA 256332RRM1 334418PRO 334418XRA 334670RAD 256487RAD 870898PROT 479BVXR 870541PROT6 870226PROT 870208RF 870208XR1 520498PR1 520498PR2 520901GERF1 928348PRO 928348PRO2 520MERPRO RADNETRAD352 310888PRO 818563DR 818461DR 707421NBSDI1 510797RM1 714537RM3 801774ER 909336RAD1 909336RAD2 760379RAD 213744PROTXR1 213744PROTXR2 310825PRO2 925370ORTHO1 925370ORTHO2 AVHRD22776 818360XR1 310374PRO 909788R2 831424RAD2 408885EDB 562493RM1 805418XR1 707429NBGV1 805652DR2 925210RAD1 303FCAUSHXR 970945CARB 720CRHIXR 970565RAD1 303320RAD1 303DHXR1 615812PROT 970945FL4 970BASRAD 970945FL4L 970624XR2 303788SEDXR 303FCLNWBXR 303730RM5 303HIPXR 303450ED 203466PROT 203319PROT 860224PROT 203688PROTLW 203852ED1 561965RAD1 813571ER2 813916XRA 352596PROM 352597RAD1 727FSEDXR1 954HCAERPRKM 850654PRO 305MCHDORAL 904264RAD1 850862PROT 333MHRX 727528RAD1 904230RM1 904399ER1 904399RADWEST 904928RAD 904MMRAD 904OPWESTER 813344PROTXR 321FCR1 305MCHWBRAD 904OPTCCRAD 850469PROT 352333PROTWD 291ERPRO 386774RM1 386774RM2 HCERPRO1 386446RM2 407359OVPRO OVERPRO 386PCHRAD3 561246RAD 727789PROT 850434BER 305MCPCPRO 813763BRPCER1 954476RAD4 954587RM1 386238FHR1 772340XR1 772SLMCER1 904819WGRAD 727341ER 727341PPER1 813282PRO1 813442XRA 863773PROT 404251P1 404686CRAD5 404686MOT2 706396COM 678207PROT1 912466PRO 912466PROT 403150 706257SFP 706335BR1 706335PRO1 229276CR3 678474PROT1 3109851 40401

UPC codes

00840682120777, 83093535827, 83109605126, 83094378263, 83135048766, 082407040377, 082407070120, 082407010123

Source

Official record: FDA (Device enforcement) ↗

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