FDA Device recall Z-2733-2024

GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973

FDA Device
Class II
ongoing
Published 2024-09-04

On 2024-09-04 the FDA classified a Class II recall of GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973 by Ge Healthcare China, citing 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 follo….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2733-2024
Classification	Class II
Status	ongoing
Initiated	2024-07-12
Published	2024-09-04
Last updated	2026-09-13 11:57 UTC
Company	Ge Healthcare China
Distribution	n/a

Product

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) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

Reason

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.

Identifiers

code_info	1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PR… 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, SDN

code_info

1) 2259973: UDI/DI none: System ID Numbers: 918485PROT1, 281410PRO; UDI/DI 00840682120777: System ID Number 503315PR…

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, SDN

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2733-2024%22

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