The Recall Desk
HighFDA (Devices)·Z-0511-2018·Announced 2018-02-14

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.

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: 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 SP
Manufacturer
Philips Medical Systems (Cleveland) Inc
Category
Medical Device — Imaging Equipment
Hazard
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.

See all 5 products in this recall →

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