• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Juno

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Juno see related information
Date Initiated by Firm December 13, 2012
Date Posted January 28, 2013
Recall Status1 Open3, Classified
Recall Number Z-0702-2013
Recall Event ID 63868
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 MA 01810
For Additional Information Contact
978-687-1501
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = RCA and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.
-
-