# FDA recall Z-2726-2026

> **GE Medical Systems, LLC** · Class II · device recall initiated 2026-06-05.

## Product

Optima XR200amx, Mobile Digital-Ready Radiographic System

## Reason for recall

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

## Distribution

Worldwide - US Nationwide and the countries of Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.

## Key facts

- **Recall number:** Z-2726-2026
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-05
- **Report date:** 2026-07-22

- **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-2726-2026

## Citation

> MORVS. FDA recall Z-2726-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2726-2026. Source: US FDA. Licensed CC0.

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