FDA Device recall Z-0811-2025

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3

FDA Device
Class II
ongoing
Published 2025-01-15

On 2025-01-15 the FDA classified a Class II recall of GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3 by Ge Medical Systems, citing GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0811-2025
Classification	Class II
Status	ongoing
Initiated	2024-11-25
Published	2025-01-15
Last updated	2026-09-13 11:57 UTC
Company	Ge Medical Systems
Distribution	n/a

Product

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB

Reason

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.

Identifiers

code_info	1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954W… 1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2; UDI/DI none, Serial Numbers: 10523MOB01, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 316858AMX200P1, 401OPTI3, 410368WP1, 443643WP1, 503251XR200, 512SDMCP1, 518243OPT2, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1, 661949DP2, 718630OPTIMAX, 760379DP, 801299SB1, 804417OPTIMA, 812237P1, 813745OPT1, 856355OPT, 904244MP1, 904244MP2, 904276DP200, 918477OPT1, 956365OPT1, 956632OPT2, 956632OPT4, XR1037005WK4; 2) 5555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1; UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100; 3) A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO.

code_info

1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954W…

1) 5555000-3: UDI/DI 00840682115278, Serial Numbers: 260665XR220, 478757OPT, 512SDERLM1, 904244MP5, 912466AMX2, 954WRMCDP2; UDI/DI none, Serial Numbers: 10523MOB01, 201418DIG1, 210297NC200M1, 229276M200, 240566P1, 316858AMX200P1, 401OPTI3, 410368WP1, 443643WP1, 503251XR200, 512SDMCP1, 518243OPT2, 603356OPTIMA, 609267OPT, 609267OPT3, 661949DP1, 661949DP2, 718630OPTIMAX, 760379DP, 801299SB1, 804417OPTIMA, 812237P1, 813745OPT1, 856355OPT, 904244MP1, 904244MP2, 904276DP200, 918477OPT1, 956365OPT1, 956632OPT2, 956632OPT4, XR1037005WK4; 2) 5555000-4: UDI/DI 00840682115278, Serial Numbers: 405717P200, 408259AP8, 518583OPT1, 773792XR200, 7982XR0277, 801230XRA, 904399MP19, 989907DP1; UDI/DI none, Serial Numbers: 1553XR0081, 316962240P1, 361572XR220C, 812265M200, A51043204, FEB520100; 3) A0659MB: UDI/DI 00840682115278, Serial Numbers: XR2262CO.

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-0811-2025%22

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