Devices

Device Recall Brightview XCT, 3/8"

Model / Serial
Model number: 4535-607-49161, catalog number 882482; Serial numbers: 6000150 6000114 6000106 6000071 6000107 6000139 6000138 6000131 6000130 6000128 6000126 6000125 6000123 6000121 6000163 6000156 6000151 6000147 6000145 6000144 6000141 6000120 6000119 6000118 6000109 6000105 6000104 6000103 6000102 6000099 6000098 6000097 6000096 6000088 6000085 6000080 6000077 6000067 6000066 6000041 6000015 6000012 6000010 6000005 6000084 6000074 6000072 6000070 6000065.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including US distribution to OH, MA, FL, VT and KY and the countries of Norway, Saudi Arabia, Belgium, Brazil, Japan, China, Poland, Austria, United Kingdom, Spain, Indonesia, Malaysia, Taiwan, Germany, United Arab Emirates, Netherland, Switzerland, Ireland, Czech Republic and Canada.
Product Description
Brightview XCT, 3/8" || Philips Medical Systems || Brightview XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrated with an attenuation device consisting of flat panel x-ray imaging components. Brightview ECT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction.
Manufacturer
Philips Medical Systems
1 Event
- Recall of Device Recall Brightview XCT, 3/8"

Manufacturer

Philips Medical Systems

Manufacturer Address
Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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