---
title: "GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numb... — FDA record Z-0811-2025 | Is It on Recall"
description: "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 Safet"
url: https://isitonrecall.com/recall/fda-device-z-0811-2025-ge-healthcare-optima-xr200amx-mobile-digital-radiographic-system-model-numbers-1-5555000-3-2-5555000/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB — FDA record Z-0811-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 25, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: GE Medical Systems, LLC
- **Quantity**: 53 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0811-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0811-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Jan 15, 2025
- **Recall initiation date**: Nov 25, 2024
- **Center classification date**: Jan 7, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0811-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [GE Medical Systems, LLC records](https://isitonrecall.com/brand/ge-medical-systems-llc/)