Philips DigitalDiagnost 3.1.x X-Ray System Recalled for Performance Issues
Philips is recalling DigitalDiagnost 3.1.x X-Ray Systems in the US due to a potential issue that may affect equipment performance under certain conditions.
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, and the source text describes a potential performance issue without reporting specific injuries, illnesses, or deaths, aligning with the criteria for moderate severity involving low-risk or theoretical hazards.
Plain-English summary
Philips Electronics North America Corporation is recalling the Philips DigitalDiagnost 3.1.x X-Ray System in the United States. The recall involves 132 units distributed nationwide to specific states, including Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
The recall was initiated after recent evaluations identified a potential issue that may affect the performance of the equipment under certain conditions. The specific nature of the performance issue is not detailed in the provided source text.
This recall is classified as Class II by the FDA. Consumers and healthcare providers with these systems should contact Philips Electronics North America Corporation for further instructions on how to address the potential performance issue.
The recalled product
- Product
- Philips DigitalDiagnost 3.1.x X-Ray System
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 132
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DigitalDiagnost Upgrade Release 3.1.x to 3.1.3
Distribution
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