Philips Recalls BrightView XCT Gamma Cameras Due to CT Scan Interruptions
Philips Medical Systems is recalling BrightView XCT gamma cameras because the CT portion of scans may be interrupted and fail to complete successfully.
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, fitting the criteria for a moderate severity score involving a defect without reported harm.
Plain-English summary
Philips Medical Systems, Inc. is recalling the BrightView XCT, a gamma camera used for Single Photon Emission Computed Tomography (SPECT) that integrates with an attenuation device consisting of flat panel x-ray imaging components. The recall was initiated after it was discovered that the CT portion of the scan could be interrupted, stopping the CT exposure at the time of interruption, and did not complete successfully.
Approximately 344 units were distributed worldwide, with about 114 units in the United States. The affected devices were distributed nationwide in the U.S., including Puerto Rico and specific states, as well as in numerous countries across the globe. The source text does not specify the number of reported injuries or illnesses associated with this defect.
Consumers and healthcare facilities should contact Philips Medical Systems for further instructions on how to address the interrupted CT scans. The source text does not provide specific consumer action steps beyond the recall notice itself.
The recalled product
- Product
- BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
- Manufacturer
- Philips Medical Systems, Inc.
- Hazard
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)
- Brightview XCT
Distribution
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