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.
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 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
- Hazard
- mechanical-failure
- patient-injury-risk
- component-assembly-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 (5)
- UDI-DI: 00840682115278
- System IDs: 419383DP3
- 773792XR200
- 856355OPT
- FEB520100
Distribution
Distributed nationwide across the United States.
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