BrightView X 3/8 model number 882478 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, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). 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 SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

Class I - Dangerous

🏥 Medical Devices Recalled: February 24, 2017 Philips Medical Systems (Cleveland) Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
11000105, 11000116, 11000018, 11000047, 11000046, 11000010, 11000068, 11000098, 11000083, 11000013, 11000107, 11000056, 11000042, 11000093, 11000089, 11000104, 11000077, 11000028, 11000085, 11000040, 11000076, 11000117, 11000058, 11000118, 11000086, 11340005, 11000064
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Recall Details

Company:: Philips Medical Systems (Cleveland) Inc
Reason for Recall:: The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

BrightView X 3/8 model number 882478 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, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). 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 SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

Product Codes/Lot Numbers:

11000105, 11000116, 11000018, 11000047, 11000046, 11000010, 11000068, 11000098, 11000083, 11000013, 11000107, 11000056, 11000042, 11000093, 11000089, 11000104, 11000077, 11000028, 11000085, 11000040, 11000076, 11000117, 11000058, 11000118, 11000086, 11340005, 11000064

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1753-2017

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