Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Juno DRF System. Mobile X-ray system These are general Recalled by Villa Radiology Systems LLC Due to It has been discovered that the Air Kerma...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Villa Radiology Systems LLC directly.
Affected Products
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Quantity: 22 units within US
Why Was This Recalled?
It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
Where Was This Sold?
This product was distributed to 16 states: AL, AZ, CA, CT, IL, IN, IA, MD, MA, MI, MS, MO, NY, OH, PA, UT
About Villa Radiology Systems LLC
Villa Radiology Systems LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report