—#114934

Product

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

FDA product code: RCA — X-Ray Controls - Fluoroscopic
Device class: Class N
Medical specialty: Unknown
510(k) numbers: K050190
Affected lot / code info: Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :

Why it was recalled

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

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

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.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA

Timeline

Recall initiated: 2012-12-13
Posted by FDA: 2013-01-28
Terminated: 2017-01-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114934. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.