{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Cleveland", "state": "OH", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "81569", "recalling_firm": "Philips Medical Systems (Cleveland) Inc", "address_1": "595 Miner Rd", "address_2": "N/A", "postal_code": "44143-2131", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-0543-2019", "product_description": "Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories", "product_quantity": "6,343 units in total", "reason_for_recall": "There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall", "recall_initiation_date": "20181018", "center_classification_date": "20181130", "termination_date": "20210803", "report_date": "20181212", "code_info": "System Serial Number: 335 1489 1897 3491 4001 4003 4016 4021 9009 9029 9030 9033 9035 9037 9038 9040 9041 9043 9044 9045 9047 9048 9051 9052 9054 9056 9058 9059 9062 9064 9065 9066 9067 9068 9069 9070 9071 9072 9073 9074 9075 9077 9080 9081 9086 9087 9089 9092 9093 9096 9098 9099 9104 9105 9106 9107 9108 9112 9117 9118 9120 9121 9122 9134 9135 9137 9138 9139 9140 9142 9143 9148 9151 9152 9156 9159 9160 9162 9163 9166 9168 9171 9172 9173 9177 9187 9190 9194 9195 9196 9197 9201 9202 9205 9206 9208 9213 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