Gamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard
Philips BrightView XCT gamma cameras may pose an extremity entrapment hazard during certain scanning operations. A gap can form between the patient support and detector, risking fractures, lacerations, and crush injuries.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a potential extremity entrapment hazard. While serious injury risks are listed (fractures, crush injuries, lacerations), the source uses 'may' and 'potential' language, indicating no confirmed injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Philips North America is recalling the BrightView XCT gamma camera (Product Code 882482), with 135 units distributed in the United States and 294 units distributed internationally.
During Pre-Programmed Motion scans used for extrinsic quality assurance testing, a gap may form between the patient support platform and the detector. This creates a potential extremity entrapment hazard. Patients may be at risk for fractures, lacerations, crush injuries, muscle or ligament strain, abrasion, or contusion.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- BrightView XCT, Gamma Camera, Product Code 882482
- Manufacturer
- Philips North America
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips North America 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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See all →- HighPhilips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard
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- HighGamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
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