Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0203-2015

October 23, 2013

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 69304
Status
Terminated
Classification
Class II
Quantity
344 units worldwide, with approximately 114 units in the United States.
Official record key
device-enforcement:Z-0203-2015

Official wording

Reason: 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.

Code information: Brightview XCT

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.