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Philips Medical Systems, Inc. recalls BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuati
Recalled December 17, 2014 · FDA recall Z-0203-2015 · Philips Medical Systems
Hazard
It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully. · FDA Class II
Units
344 units worldwide, with approximately 114 units in the United States.
Sold at
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, DC, DE, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA and WI., and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom and Viet Nam.
Description
It was discovered the CT portion of the scan was interrupted ( stopping the CT exposure at the time of interruption) and did not complete successfully.
Product
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.
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →