Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors
Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.
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: The recall involves a medical device where displayed radiation dose values may be significantly inaccurate (deviation >35%), posing a risk of harm due to potential overexposure or underexposure, but no injuries or illnesses are reported in the source text.
Plain-English summary
Villa Radiology Systems LLC is recalling 22 units of the Juno DRF System, a mobile X-ray system used for routine radiographs and general fluoroscopy procedures. The recall affects units distributed across 16 US states, including Arizona, Michigan, Indiana, Utah, Connecticut, Alabama, New York, Pennsylvania, Illinois, Maryland, California, Massachusetts, Iowa, Ohio, Mississippi, and Missouri.
The recall was initiated because the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6"). This inconsistency could result in displayed values for Air Kerma Rate and Cumulated Air Kerma deviating from actual values by more than +/-35%. Such deviations represent a failure to comply with the requirements of 21 CFR 1020.32(k)(6).
Healthcare facilities and users of these systems should contact Villa Radiology Systems LLC for instructions on how to resolve the issue. The source text does not specify a specific action for consumers, but the affected units are professional medical devices.
The recalled product
- Product
- Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Manufacturer
- Villa Radiology Systems LLC
- Affected units
- 22
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)
- PN 709020
Distribution
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