Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.
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 FDA Class II recall involves a potential extremity entrapment hazard in a medical device. The source describes potential injuries but reports no actual incidents, meeting the criteria for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America is recalling the BrightView X Gamma Camera (Product Code 882478) due to a potential extremity entrapment hazard during quality assurance imaging scans.
During pre-programmed motion quality assurance procedures, a gap may form between the patient support and the detector head. This gap creates a potential extremity entrapment hazard that could affect patients.
Potential injuries from extremity entrapment include fracture, loss of function or debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, and contusion.
The recalled devices are distributed nationwide in the United States and internationally.
The recalled product
- Product
- BrightView X, Gamma Camera, Product Code 882478
- Manufacturer
- Philips North America
- Category
- Medical Device
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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