Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard
Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.
What this means for you
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 medical device recall involves a potential extremity entrapment hazard that could result in serious patient injuries such as fracture, crush injury, and loss of function. However, no injuries, deaths, or hospitalizations have been reported to date, placing this in the High category as a risk-of-harm product without reported injury.
Plain-English summary
The BrightView Gamma Camera System (Product Code 882480), manufactured by Philips North America, is being recalled due to a potential patient safety hazard.
During quality assurance scanning using the Pre-Programmed Motion feature, a gap can form between the patient support and the detector. This gap creates an extremity entrapment hazard that may result in serious injuries, including fracture, loss of function, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.
The recall affects 359 units in the United States and 328 units distributed internationally. Users of the affected devices should contact Philips North America for guidance on corrective measures. No injuries have been reported related to this hazard.
The recalled product
- Product
- BrightView, Gamma Camera System, Product Code 882480.
- Manufacturer
- Philips North America
- Category
- Medical Device — Medical Imaging
- Hazard
- extremity-entrapment
- crush-injury
- fracture
- laceration
Distribution
Distributed nationwide across the United States.
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