Philips BrightView XCT Gamma Camera Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView XCT gamma cameras because a collimator may drop to the floor during exchange, posing a risk of injury.
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: The recall involves a risk-of-harm product (falling heavy equipment) where injury has not yet been reported, fitting the 'High' severity criteria for potential physical injury without confirmed cases.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 1,387 units of the BrightView XCT Model 882482 gamma camera. The recall is due to a potential mechanical failure during the collimator exchange process. The affected devices are distributed worldwide, including nationwide in the United States.
During the exchange of the collimator, the alignment of the collimator cart and detectors may cause the exchange to fail. In such cases, a collimator may drop to the floor beside the cart. The collimator may be partially supported by the cart, such as leaning against it, or it may fall or slide completely to the floor. This presents a risk of injury to personnel in the vicinity.
Healthcare professionals using these devices should contact Philips Medical Systems for instructions on how to resolve the issue. The recall covers specific serial numbers listed in the official FDA record Z-0511-2018.
The recalled product
- Product
- BrightView XCT Model 882482 Product Usage: 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. BrightView XCT produces non-attenuation corrected…
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 1,387
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Philips Medical Systems (Cleveland) Inc 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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