The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · GE Medical Systems, LLC

See all →

Same hazard · equipment failure

See all →