Reported Sep 25, 2013 · Terminated
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and…
Villa Radiology Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Villa Radiology Systems LLC · 91 Willenbrock Rd Ste B1 · Oxford, CT · 06478-1036
Is this the product you have?
- Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
- Lot codes and dates
- PN 709020
- Amount recalled
- 22 units within US
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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