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.
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 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
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
Same hazard · extremity entrapment
See all →- HighGamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance
FDA (Devices) · 2024-01-17
- HighGamma Camera Recalls Due to Potential Patient Extremity Entrapment Hazard
FDA (Devices) · 2024-01-17
Similar recalls
- SevereBrightView Gamma Camera Detector May Fall and Injure Patients
FDA (Devices) · 2024-02-14
- ModeratePhilips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues
FDA (Devices) · 2016-03-09
- SevereBrightView X Gamma Camera Detector May Fall, Causing Patient Injury
FDA (Devices) · 2024-02-14
- ModeratePhilips BrightView X Gamma Camera Recall Due to Brake Hub Assembly Error
FDA (Devices) · 2017-04-12
- HighPhilips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect
FDA (Devices) · 2017-04-12
- HighPhilips BrightView X Gamma Camera Recall for Brake Hub Assembly Error
FDA (Devices) · 2017-04-12