Medium risk Drugs & MedicationsClass II

GE Medical Systems, LLC Recall

Optima XR220amx, Mobile Digital-Ready Radiographic System

Updated June 5, 2026

GE Medical Systems, LLC is recalling Optima XR220amx, Mobile Digital-Ready Radiographic System. Hazard: 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.

Is the GE Medical Systems, LLC recalled? Yes. This product was recalled by FDA on June 5, 2026. Details below.

What is recalled

Optima XR220amx, Mobile Digital-Ready Radiographic System

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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.

Brands affected

Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-2727-2026
Classification
Class II
Recalled
June 5, 2026
Read the official notice

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