Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error
Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.
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 is classified as FDA Class II. The hazard involves a mechanical failure (detector backdrive) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips Medical Systems (Cleveland) Inc. is recalling BrightView X 3/4 gamma cameras, model number 882479. These devices are used for nuclear imaging and Single Photon Emission Computed Tomography (SPECT) studies.
The recall was initiated because the brake hub was not engaging with the gearbox shaft. This issue resulted from an error in the assembly of components within the brake hub mechanism after service. The malfunction causes the detector to backdrive.
The affected units were distributed worldwide, including in the United States, Canada, and Mexico. Specific accounts include various VA hospitals, Canadian medical centers, and one Mexican medical supplier. Healthcare professionals using these devices should contact Philips Medical Systems for further instructions on the recall.
The recalled product
- Product
- BrightView X 3/4 model number 882479 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, gated, an
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None
Distribution
Part of a larger recall action
This product is one of 4 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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