Recall Z-0702-2013 ยท RCA X-Ray Controls - Fluoroscopic
Philips Healthcare Inc.
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
| Date | Jan 28, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21 |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Medical issued a notification by letter dated December 13, 2012. via Certified Mail to affected customer. The letter identified the affected product, problem and actions to be taken. Philips will contact affected customers to schedule an upgrade of the equipment . For questions or support concerning this issue, please contact Dominic Siewko at 978-659-7936. |
| Quantity | 16 units |
| Distribution | US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |