FDA Device recall Z-0550-2025
GE Proteus XR/A radiographic system
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of GE Proteus XR/A radiographic system by Ge Healthcare China, citing 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 L….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0550-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-24 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare China |
| Distribution | US |
Product
GE Proteus XR/A radiographic system
Reason
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.
Identifiers
| code_info | UDI-DI: 00840682120777; System ID: 907443PROTEUS 251847RAD 256737PRO 251435PROT 251275RAD 251275RAD2 256486XR1 256429CR…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 9 |
|---|
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-0550-2025%22
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