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
- Hazard
- equipment-failure
- patient-injury-risk
- mechanical-defect
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.
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