Philips Juno DRF X-ray System Recalled for Display Compliance Issues
Philips Healthcare is recalling 16 Juno DRF X-ray systems because fluoroscopy dose values may not display correctly at the operator's position.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a regulatory compliance issue regarding display accuracy, fitting the 'Moderate' criteria for low-risk issues without reported harm.
Plain-English summary
Philips Healthcare Inc. is recalling 16 units of the Juno DRF X-ray system, Model 70920. This diagnostic fluoroscopic system is used for general-purpose radiography and fluoroscopy.
The recall was initiated because values for fluoroscopy time, Air Kerma Rate, and Cumulated Air Kerma may not be displayed at the fluoroscopist's working position, which fails to meet the requirements of 21 CFR 1003.21. This regulatory non-compliance could prevent operators from accurately monitoring radiation dose levels during procedures.
The affected units were distributed nationwide in the United States, including Alabama, California, Colorado, Connecticut, Illinois, Maryland, Michigan, Missouri, New York, Ohio, and Pennsylvania. Healthcare facilities should contact Philips Healthcare for instructions on how to resolve the display issue.
The recalled product
- Product
- Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 16
Distribution
Related recalls
Same manufacturer · Philips Healthcare Inc.
See all →- ModeratePhilips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error
FDA (Devices) · 2017-04-12
- HighPhilips IntellVue Info Center Patient Monitor Recall for Reboot Loop
FDA (Devices) · 2014-06-18
- ModeratePhilips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation
FDA (Devices) · 2013-09-04
- LowPhilips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
FDA (Devices) · 2013-08-28
- ModeratePhilips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss
FDA (Devices) · 2013-07-31
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01