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Terminated

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

FDA Recall Z-0702-2013 · Posted 2013-01-28

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeRCA
Date Initiated2012-12-13
Date Terminated2017-01-24
Product Quantity16 units

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

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050190APOLLOVilla Sistemi Medicali S.P.A. · 2005-03-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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