Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
This recall has been terminated (originally issued January 28, 2013).
- Company
- Philips Healthcare Inc.
- Recall Initiated
- December 13, 2012
- Posted
- January 28, 2013
- Terminated
- January 24, 2017
- Recall Number
- Z-0702-2013
- Quantity
- 16 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
Lot / Code Info
Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
Root Cause
Radiation Control for Health and Safety Act
Action Taken
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.