Recall Z-0702-2013— Philips Healthcare Inc.

Name: FDA recall Z-0702-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-13

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-12-13, terminated 2017-01-24. It names one FDA 510(k) clearance: K050190. Product: Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use. Reason: 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.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Terminated: 2017-01-24
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K050190 — APOLLOVilla Sistemi Medicali S.P.A.·cleared 2005-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.