Agency classClass IIOur severity:High FDA (Devices)·Z-2726-2026·Announced 2026-07-22

GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall

GE HealthCare recalls certain Optima XR200/220/240amx mobile radiographic systems where safety testing may have been incomplete after column replacement. A failed counterpoise cable could cause the X-ray arm to drop on patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device where a structural/mechanical failure could result in patient injury (arm dropping on patient). The source text indicates the hazard is real but does not report any illnesses or injuries to date, placing it at the High level per the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling certain Optima XR200/220/240amx Mobile Digital-Ready Radiographic Systems. The recall affects 4 units distributed worldwide, including the United States and internationally (Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK). The affected systems have had a column replacement completed.

The issue is that functional testing of the safety pawl may not have been performed to confirm proper assembly after the column replacement. If the internal counterpoise cable fails, the Column Safety mechanism will not function properly. This could cause the arm carrying the X-ray tube and collimator to drop downward on the column track, potentially resulting in patient injury during an exam.

Patients and healthcare facilities using these systems should contact GE HealthCare immediately to arrange for proper safety testing and verification of the column assembly. The affected systems are identified by UDI-DI: 00840682115278 and System IDs: 419383DP3, 773792XR200, 856355OPT, FEB520100.

The recalled product

Product: Optima XR200amx, Mobile Digital-Ready Radiographic System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Radiographic Equipment
Hazard: mechanical-failure
patient-injury-risk
component-assembly-defect
Affected units: 4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

UDI-DI: 00840682115278
System IDs: 419383DP3
773792XR200
856355OPT
FEB520100

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · GE Medical Systems, LLC

See all →

High
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
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Same hazard · mechanical failure