Siemens Mobilett Mira wireless x-ray systems recalled for buzzer mounting defect
Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The missing acoustic notification is a functional defect, but the x-ray system operates correctly and a visual LED indicator provides an alternative monitoring method, significantly mitigating the hazard.
Plain-English summary
Four Siemens Medical Solutions USA, Inc. Mobilett Mira wireless (VA20) mobile x-ray systems (model 10273100, UDI 04056869009117) are being recalled. The affected devices have serial numbers 1511, 2168, 2525, and 2633.
The systems have an incorrectly mounted buzzer component that fails to produce an acoustic signal when x-ray activation occurs. This prevents operators from receiving the intended auditory notification of x-ray exposure.
Despite this defect, the x-ray systems otherwise function correctly and deliver x-rays as intended. A visual indicator in the form of an exposure LED light remains functional for monitoring x-ray release, and clinical images display normally on the monitor after successful x-ray exposure.
Operators should be aware that acoustic notification will not occur during x-ray activation and should rely on the visual LED exposure indicator to confirm x-ray release. Facilities with these systems should review their operating procedures to ensure operators are fully aware of this equipment limitation.
The recalled product
- Product
- Mobilett Mira wireless (VA20) mobile x-ray system(s)
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 4
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 (1)
- Model Number 10273100 / UDI 04056869009117 Serial 1511 2168 2525 2633
Distribution
Distributed nationwide across the United States.
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