FDA-Device2013-02-06Class II

Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

Philips Healthcare Inc.
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

Sold states
US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
Affected count
16 units
Manufactured in
3000 Minuteman Road, Andover, MA, United States
Products
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0702-2013

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