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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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