BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. 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 x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the 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.
FDA Recall Z-0089-2014 · Posted 2013-10-28
Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA including AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, KY, MA, MD, MN, MO, MS, MT, NC, NJ, ND, NE, NV, NY, OH, OK, OR, PA, SD, TX, VT, WA, and WI. Internationally to Canada, Algeria, Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, Finland, France, Gabon, Germany, India, Indonesia, Ireland, Italy, Japan, Korea Republic, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.