{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130194", "product_res_number": "Z-0203-2015", "event_date_initiated": "2013-10-23", "event_date_posted": "2014-12-12", "recall_status": "Terminated", "event_date_terminated": "2021-03-01", "res_event_number": "69304", "product_code": "KPS", "k_numbers": [ "K080927" ], "product_description": "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_info": "Brightview XCT", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems, Inc.", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "978-687-1501", "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.", "root_cause_description": "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. \n\nAction to be taken by the customer:\n\nPlease 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.\n\nPhilips 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.\n\nIf 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).", "product_quantity": "344 units worldwide, with approximately 114 units in the United States.", "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.", "openfda": { "k_number": [ "K013504", "K113448", "K031705", "K001276", "K073021", "K926133", "K240827", "K011572", "K131634", 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