The Recall Desk
HighFDA (Devices)·Z-0812-2025·Announced 2025-01-15

GE Optima XR Mobile Radiographic System Column Safety Mechanism Defect

GE Healthcare Optima XR mobile X-ray systems with column replacements may have missing bolts in the Column Safety mechanism. If bolts are missing and the internal cable fails, the arm could drop, creating a risk of injury to staff or patients.

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 medical device recall with no reported injuries, hospitalizations, or deaths. However, it describes a safety mechanism defect (missing bolts in the Column Safety mechanism) that could result in equipment failure and drop hazard if the internal counterpoise cable also fails. Per the rubric, risk-of-harm medical devices where injury has not yet been reported score as High (3).

Plain-English summary

GE Healthcare has recalled certain Optima XR200/220/240amx mobile digital radiographic systems distributed worldwide. The systems that underwent column replacement are potentially affected.

Following column replacement, some bolts in the Column Safety mechanism can be missing. If bolts are absent and the internal counterpoise cable fails, the safety mechanism will not function properly and the arm carrying the X-ray tube and collimator may drop downward on the column track.

This defect creates a potential risk of injury to operators and patients. Healthcare facilities should contact GE Medical Systems, LLC to determine if their equipment is affected and to arrange inspection or repair as needed.

The recalled product

Product
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — X-ray Equipment
Hazard
Affected units
281

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)

  • 1) 5555000-12: UDI/DI none
  • Serial Numbers: 082407100532
  • UDI/DI to be provided
  • Serial Numbers: 082407160512
  • 2) 5555000-5: UDI/DI 840682115261
  • Serial Numbers: 1557XR0205
  • 352867XRA
  • 478765CDP1
  • 509962KV220
  • 601358OPTX220
  • 620421P3
  • 813872OPT3
  • SB2201700099WK
  • UDI/DI none
  • Serial Numbers: 479314220
  • 00028MOB12
  • 203694SB3
  • 205820DP1
  • 208666KDM
  • 209334OPT1

Distribution

Distribution scope not specified by the agency.

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

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Same hazard · mechanical defect

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