Philips BrightView XCT Medical Device Recalled for Intended Use Labeling Mismatch
Philips is recalling BrightView XCT systems because the intended use in the instructions for use did not match the 510K submission.
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 involves a documentation/labeling discrepancy (intended use mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling BrightView X upgraded to XCT 882454 medical devices. The recall was initiated because the intended use listed in the English and localized language Instructions for Use (IFUs) did not match the intended use documented in the 510K submission.
The affected products were distributed in the United States to Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Vermont, Washington, and Wisconsin. The products were also distributed internationally to numerous countries including Australia, Canada, China, Germany, Japan, and the United Kingdom.
No specific instructions for consumers are provided in the source text. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BrightView X upgraded to XCT 882454
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Imaging
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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