||January 28, 2013
|Recall Event ID
X-Ray Controls - Fluoroscopic - Product Code RCA
||Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose
Universal R/F, general use
|Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
|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
|RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
||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 in Commerce
||US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = RCA and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.