FDAFDA · Food and drugs·Recall number Z-0702-2013
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Published February 6, 2013 · Recall initiated: December 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Inc.
- Distributor
- US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
- Lot
- Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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