Philips BrightView Gamma Cameras Recalled for Collimator Drop Risk
Philips Medical Systems is recalling BrightView Model 882480 gamma cameras because collimators may drop to the floor during exchange, posing a physical hazard.
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 theoretical or unreported physical hazards.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling 1,387 units of the BrightView Model 882480 gamma camera. These devices are designed for single or dual detector nuclear imaging and are distributed worldwide, including across the United States.
The recall is due to a mechanical issue during the collimator exchange process. The alignment of the collimator cart and detectors may cause the exchange to fail, resulting in the collimator dropping to the floor beside the cart. The collimator may fall or slide completely to the floor, or it may be partially supported by the cart, such as leaning against it.
No specific illnesses or injuries are reported in the source text. Affected units are identified by specific serial numbers listed in the recall documentation. Users should contact the manufacturer for instructions on how to address this defect.
The recalled product
- Product
- BrightView Model 882480 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic…
- 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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