{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94330", "product_res_number": "Z-0022-2011", "event_date_initiated": "2010-09-09", "event_date_posted": "2010-10-07", "recall_status": "Terminated", "event_date_terminated": "2011-07-22", "res_event_number": "56707", "product_code": "KPR", "k_numbers": [ "K982795" ], "product_description": "The BABIX holder is an accessory used with the DigitalDiagnost X-ray system. It is used to hold the baby either in a secured or immobilized standing position in front of the X-ray detector during the examination.", "code_info": "Devices are identified as Site Number: 536043", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Healthcare Call Center\n425-487-7602", "reason_for_recall": "Potential of broken strands in the main steel cable supporting the accessory holder used with BuckyDiagnost and DigitalDiagnost X-ray systems.", "root_cause_description": "Equipment maintenance", "action": "Philips issued URGENT-Device Correction Notice letters dated September 9, 2010 to their consignees identifying the affected products and action to be taken by customers. The letter states that Babix holder used with Philips BuckyDiagnost and DigitalDiagnost X-Ray System - VS Wall Stand Risk of steel cable fracture in the support holder. The consignees are informed that there is a potential of broken strands at the main steel cable within the holder which cannot be recognized by the user. The firm will issue the Field Change Order (FCO) and the Service Engineer will replace the Babix holder.\nConsignees can call Philips Call Center at 800-722-9377, #5 (then follow prompts) and reference to FCO 70400038 for the BuckyDiagnost X-ray system and FCO 71200046 for the DigitalDiagnost X-ray system.", "product_quantity": "1 unit", "distribution_pattern": "Nationwide Distribution in the states of CA, GA, and TN.", "openfda": { "k_number": [ "K110849", "K221853", "K080655", "K181279", "K051258", "K083109", "K181629", "K872525", "K990715", "K231761", "K071430", "K855161", "K201670", "K233662", "K811142", "K811807", "K230241", "K193637", "K102408", "K012546", "K214012", "K781613", "K082798", "K101686", "K902606", "K853330", "K852349", "K936087", "K942792", "K861994", "K945708", "K180663", "K151419", "K990242", "K941592", "K072659", "K942581", "K920347", "K973710", "K233722", "K162529", "K080553", "K163410", "K142049", "K233530", "K162224", "K150816", "K190330", "K921112", "K790685", 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