FDAFDA · Food and drugs·Recall number Z-2160-2013
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Published September 25, 2013 · Recall initiated: August 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Villa Radiology Systems LLC
- Distributor
- US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
- Lot
- PN 709020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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