{ "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": "79567", "product_res_number": "Z-0897-2011", "event_date_initiated": "2009-01-26", "event_date_posted": "2011-01-12", "recall_status": "Terminated", "event_date_terminated": "2011-01-13", "res_event_number": "51274", "product_code": "INQ", "k_numbers": [ "K051351" ], "product_description": "Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system,\n\nModel Number: 4535 602 50851, Catalog Number: 882350,\n\nProduct is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH \n\nIntended use: A single photon nuclear medicine and image from an X-ray computed tomography system.", "code_info": "Serial Numbers: 3000037, 3000048", "firm_fei_number": "1525965", "recalling_firm": "Phillips Nuclear Medicine", "address_1": "540 Alder Dr Bldg 4 540 Alder Dr", "address_2": "Bldg 4", "city": "Milpitas", "state": "CA", "postal_code": "95035-7443", "additional_info_contact": "408-321-9100", "reason_for_recall": "A problem has been identified with some upper patient pallets on Precedence SPECT/CT System, which may reduce its load bearing capacity and may result in its cracking. If this were to happens, could pose a risk to patient.", "root_cause_description": "Process change control", "action": "The firm, Philips Healthcare, sent an \"Urgent - Field Safety Notice\" dated January 26, 2009 to all consignees/customers. The notice described the product, problem and action to be taken by customers and by Philips. The customers were instructed to reference their system's System Operation and System information Manuals regarding loading and unloading of patient; monitoring the patient during a study ,and careful monitoring during unsupported (cantilevered) table translation. Philips has ordered replacement parts and they will have a Philip Healthcare Field Service Engineer contact and visit the customers site within two months to replace the affected upper patient pallet.\n\nIf you need any further information or support concerning this issue, please contact your local Philips representative at: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: and Oncology or your local Philips Healthcare office.", "product_quantity": "2 units", "distribution_pattern": "International distribution only: Mexico and Saudi Arabia.", "openfda": { "k_number": [ "K834103", "K932746", "K830289", "K861352", "K924905", "K950872", "K822221", "K932412", "K923973", "K952358", "K925164", "K930692", "K830855", "K932236", "K885276", "K902549", "K950873", "K951382", "K934754", "K942256", "K950361", "K830874", "K950364", "K952359", "K932232", "K952355", "K960196", "K852651", "K952441", "K952600", "K905647", "K843877", "K953621", "K924093", "K830849", "K960332", "K960336", "K952357", "K844712", "K941720", "K932237", "K933119", "K864817", "K920585", "K894017", "K932749", "K841594", "K854635", "K933727", "K854947", "K950874", "K830633", "K841145", "K851007", "K923325", "K902234", "K905685", "K850377", "K932241", "K951419", "K942026", "K950363", "K924002", "K904950", "K943972", "K832804", "K883659", "K771202", "K951955", "K933577", "K930802", "K951954", "K922719", "K933621", "K925563", "K902971", "K933578", "K810125", "K923998", "K933581", "K944329", "K932235", "K951906", "K950360", "K940131", "K950362", "K951952", "K936303", "K933622", "K931832", "K951953", "K951323", "K952356", "K941281", "K953622", "K942109", "K960334", "K933580", "K932239", "K823150", "K925594", "K924019" ], "registration_number": [ "3014302716", "3007031002", "3008960494", "3031582440", "3016678044", "3020889880", "3002649826", "2518399", "3005843419", "3013873584", "3008899703", "3035374386", "2510425", "3010067993", "3003755374", "3007278668", "3003548115", "3010373263", "3027847726", "3025488993", "3011537487", "3014739961", "1415746", "9612147", "3003947878", "3007583774", "3030488262", "3007420694", "1000206677", "3016590299", "2242467", "3045317904", "9616877", "3026311463", "3008887767", "3008804905", "1649977", "3017264244", "2183634", "3031214267", "3007028274", "3037012186", "3007515312", "3008729549", "3001657382", "3008261413", "2182762", "2939821", "3001452523", "3009307605", "3008956940", "1717548", "3012404688" ], "fei_number": [ "3014302716", "3007031002", "3008960494", "3031582440", "3016678044", "3020889880", "3002649826", "3002552319", "3005843419", "2518399", "3013873584", "3035374386", "2510425", "3010067993", "3003755374", "3007278668", "3003548115", "3010373263", "3027847726", "3008879703", "3025488993", "3011537487", "3014739961", "1415746", "3002806913", "1000080794", "3001853068", "3003947878", "3007583774", "3030488262", "3007420694", "1000206677", "3016590299", "3045317904", "3026311463", "3008887767", "3008804905", "3017264244", "1000124207", "2183634", "3031214267", "3007028274", "3037012186", "3007515312", "3008729549", "3001657382", "3008261413", "2182762", "3001452523", "3009307605", "3008956940", "1717548", "3012404688" ], "device_name": "Table, Powered", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3760", "device_class": "1" } } ] }