Z-0702-2013Class II

Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920

Name: Z-0702-2013 Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920
Creator: Philips Healthcare Inc.
Published: 2012-12-13
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-12-13 / Terminated

FDA source

Philips Healthcare Inc. began a recall of Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use on 2012-12-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0702-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-01-28
Terminated: 2017-01-24
Recalling firm: Philips North America LLC
Product: Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
Product code: RCA X-Ray Controls - Fluoroscopic
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
FDA root cause: Radiation Control for Health and Safety Act
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.
Quantity in commerce: 16 units
Distribution: US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY, OH, PA
Product codes and lots: Serial Numbers: 10110770 11030805 11070848 11070845 11070849 11030806 11090864 11110900 12020982 114087 12030999 12061020 12041003 12061014 12061018 12081040 :

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0702-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-28

Product code RCA

K050190Class IIApolloVilla Sistemi Medicali S.P.A. / cleared 2005-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)