Agency classClass IIOur severity:High FDA (Devices)·Z-2728-2026·Announced 2026-07-22

Mobile Digital Radiographic System Arm Drop Risk During Patient Exams

GE HealthCare is recalling certain Optima XR200/220/240amx Mobile Digital Radiographic Systems due to potential failure of the Column Safety mechanism, which could cause the X-ray arm to drop during patient exams. The issue stems from incomplete functional testing of the safety pawl after column replacement.

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 with a risk-of-harm mechanism (potential patient injury from a falling X-ray arm during examination). No injuries have been reported in the source text, making this a High-severity hazard where the injury has not yet been reported, per the rubric.

Plain-English summary

GE HealthCare is recalling 24 units of the Optima XR200/220/240amx Mobile Digital Radiographic System worldwide, including units distributed in the US, Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, and the UK. In certain 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 in an untested system, the Column Safety mechanism will not work, causing the arm with the X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an examination.

Affected systems are identified by specific UDI-DI codes (00840682122351 and 00840682123686) and multiple system IDs listed in the recall notice. Healthcare facilities should immediately verify whether they operate any of these systems and contact GE HealthCare for further instructions regarding testing and repair.

The recalled product

Product: Optima XR240amx, Mobile Digital Radiographic System
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — Diagnostic Imaging / Radiography
Hazard: equipment-failure
patient-injury-risk
mechanical-defect
Affected units: 24

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 (20)

UDI-DI: 00840682122351 and 00840682123686
System IDs: 252847PP249
281MSL2402
291OPTI1
312CCHSUPER7
318487OPTIMA1
360744OPT2402
501686OPTI1
504826XR241
519941XR240A
540776ODP3
541472M4
602344240C
706291BEE9
713799XR240
770836BEE2
813872OPT11
813872OPT9
843724OPT1
843847OPT240

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 →

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