Philips BrightView XCT Recalled for Intended Use Documentation Mismatch
Philips Medical Systems is recalling 425 BrightView XCT systems because the intended use listed 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, but the source text indicates a documentation mismatch regarding intended use with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 425 units of the BrightView XCT medical device. 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 28 U.S. states and the District of Columbia, as well as internationally to 38 countries including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. The source text does not specify the exact dates of distribution or the specific facilities where the devices are installed.
No illnesses or injuries have been reported in connection with this recall. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- BrightView XCT
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 425
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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