Class 2 Device Recall BrightView XCT System Tomography Computed Emission

• Date Initiated by Firm: October 23, 2013
• Date Posted: December 12, 2014
• Recall Status: Terminated on March 01, 2021
• Recall Number: Z-0203-2015
• Recall Event ID: 69304
• 510(K)Number: K080927
• Product Classification: System, tomography, computed, emission - Product Code KPS
• 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.
• Code Information: Brightview XCT
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc.; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: 978-687-1501
• Manufacturer Reason for Recall: 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 Determined Cause: Radiation Control for Health and Safety Act
• Action: Philips sent an Important Electronic Product Radiation Warning letter dated November 4, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the customer: Please be aware that if this condition occurs, users will not be able to detect the situation prior to the interruption of the CT acquisition. However, if the INFORMATION message appears during a clinical study indicating to the operator that the scan did not complete successfully, Philips advises users to understand the following available options, and use their clinical judgment to determine which option best suits their clinical needs: The operator chooses not to rescan the patient: Continue with the SPECT portion of the of the scan and use only the portion of the segments that were acquired prior to the interruption for interpretation; or The operator chooses to rescan the patient: Retry the interrupted segment acquisition. Philips Healthcare is initiating a corrective action consisting of : Distribution of this Field Safety Notice 88200485_486, Conducting the appropriate field safety correction will address the above issue that has been identified. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377: follow the prompts).
• Quantity in Commerce: 344 units worldwide, with approximately 114 units in the United States.
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.