# FDA recall Z-0813-2025

> **GE Medical Systems, LLC** · Class II · device recall initiated 2024-11-25.

## Product

GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers:    1) 5555000-27;   2) 5555000-31;   3) 5555000-33;    4) 5555000-41;  5) 5555000-47;   6) A0700DL;   7) A1700DA;   8) To be provided.

## Reason for recall

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.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0813-2025
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-25
- **Report date:** 2025-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2025

## Citation

> AI Analytics. FDA recall Z-0813-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0813-2025. Source: US FDA. Licensed CC0.

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