Class 2 Device Recall Proteus XR/A

• Date Initiated by Firm: October 24, 2024
• Date Posted: November 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0550-2025
• Recall Event ID: 95674
• 510(K)Number: K993090
• Product Classification: System, x-ray, stationary - Product Code KPR
• Product: GE Proteus XR/A radiographic system
• Code Information: 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 40401XRGEPRO3 404501P1 912369PROT 912369PROT2 678639PROT 706468XR 229890CR4 770252NR2 770252GBJ3 770434PROT 404251PROT 912754PROT2 706886SR1 770456PRODIG 706678RAD 912287R608 706554MSR1 808873PROA 641424PROT 515832XRA 208785RAD 208359PROT 630315NWMBL1 630946STPROT1 1000001199 312878W8R3 773564WPRO1 630968PRO 630545PROT2 630545PROT3 630545PROT4 847543CLCF 630856PRO1 217732LPR1 630246PROT1 630246PROT2 815300PVPROT 7087471633 7087471635 630545PROT 815439RAD 618282RBRM2 708WSBCPROT1 708783PRO1 1000004588 630653OAD3 630933PROT2 219921PROT 812343PROT 574264PROT 574523EG1 574535PRO 574772PRO 765455PROT 812847PROT 574753PRT3 574753PRT4 765254PROT 219836PRO1 219836PRO2 812237TH1 812238FPCRAD 620842PRO 620429PRO 316558PRO 620397PRO 620340ORTHO 785354PROT2 620378RAD 620724CX2 620665PRO 913684CPRO 913323XRA 620257PRO 620886PRO 785475PRO 913397PROTKM 913396XRA 620332PROT 785543PRO 620672PRO 785354PROTK1 785354PROTN1 785357PROT 785743PRO 316721WWRAD2 316962ERPRO1 316962PRO 316962WCPRAD 606928PROT 513584PRO5 502624R7 502868RAD2 502868PRO1 606433PROT 606723PROT 606598XR1 606759PRO2 859987PROT 502726RAD1 606679PROT 318769ERM2 318675UFC 318878PRO 337981R3 985SMR2 504FCMCPRO 318728PRO 985WCRAD1 978249ER1 508676CR4 508676PCR2 508867CR3 508457FR1 508FHCMRAD 508SANBR1 781762RM1 508833SHRAD 508676PCR1 508828ER1 443481OSM1 301868R 301877RAD3 410740R1 301891PROT4 207255RAD1 207662PRO 906483XRA564 734446PROT 313359PROT 517353XR1 517353XR2 248615PROT 1000001522 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• Recalling Firm/ Manufacturer: GE Healthcare (China) Co., Ltd.; 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area; Beijing China
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/24/24 was sent to customers. Actions to be taken by Customer/User " You can continue to use the system for table exams without limitations. " You can continue to use the wall stand for exams where the patient does not have any part of their body underneath the bucky. " Do not perform exams where the patient has any body part underneath the bucky until the Wall Stand steel cable has been inspected and if necessary, has been replaced. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to RECALL.17148@gehealthcare.com GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 956 systems
• Distribution: Worldwide - US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPR