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U.S. Department of Health and Human Services

Class 2 Device Recall Juno

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 Class 2 Recall
Juno
see related information
Date Posted January 28, 2013
Recall Status1 Open
Recall Number Z-0702-2013
Recall Event ID 63868
Premarket Notification
510(K) Number
K050190 
Product Classification X-Ray Controls - Fluoroscopic - Product Code RCA
Product Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Code Information Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
Recalling Firm/
Manufacturer
Philips Healthcare Inc.
3000 Minuteman Road
Andover, Massachusetts 01810
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: 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 in Commerce 16 units
Distribution 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) Database 510(K)s with Product Code = RCA and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.
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