{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190362", "product_res_number": "Z-0280-2022", "event_date_initiated": "2021-05-01", "event_date_created": "2021-11-24", "recall_status": "Open, Classified", "res_event_number": "89039", "product_code": "KPS", "k_numbers": [ "K051170" ], "product_description": "Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16\nSystem Number: 882470\n\nContinuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.", "code_info": "Serial Number:\n7084\n7145\n7584", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part", "root_cause_description": "Device Design", "action": "Philips notified U.S. consignees by \"URGENT - Field Safety Notice Medical Device Correction\" FSN 72800751 for CT consignees and FSN 88200530 for PET/CT consignees via USPS Certified mail on 5/1/21. Non-U.S. customers will receive the letter through Philips Global Markets following local regulations. Letter states reason for recall, health risk and action to take:\nBe aware of this hazard when the safety clip is missing from the joint assembly\nbetween the Monitor Bracket Assembly and the Ceiling Suspension Arm.\n\" Inspect the joint area of your CCT DVI Ceiling Mount Arm (the circled area in picture at the right) and observe that the safety clip is installed (as depicted in pictures below).\n\" When this hazard occurs, the monitor may become difficult to rotate relative\nto the Suspension Arm.\n\nWhen these symptoms are recognized, in order to avoid the occurrence of a\nhazardous situation, take the following actions:\n stop using the suspension monitor clinically\n move the monitor arm away from any person\n call Philips Service for repairs.\nPlease acknowledge the receipt of this notice by completing, signing, and\nreturning the form to the indicated email address: CTNM.QARA@Philips.com.\n\nPhilips is inspecting the affected units and, if necessary, repairing joint safety components and joint wear components by FCO 72800751 and FCO 72800752 for CT consignees, and FCO 88200530 and FCO 88200531 for AMI consignees, respectively.\n\nIf you need any further information or support concerning this issue, please\ncontact your local Philips representative: For North America, contact the\nCustomer Care Solutions Center (1-800-722-9377, follow the prompts).", "product_quantity": "3 units", "distribution_pattern": "US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: \nAustralia, Germany, Netherlands and Saudi Arabia.", "openfda": { "k_number": [ "K981553", "K033254", "K926206", "K082506", "K093514", "K980715", "K042880", "K033782", "K123599", "K243186", "K011572", "K013353", "K923736", "K973396", "K991129", "K070589", "K041543", "K925186", "K936001", "K050366", "K162736", "K914296", "K161674", "K926133", "K261315", "K972509", "K121019", "K090178", "K201933", "K982387", "K181468", "K971878", "K123646", "K042863", "K221932", 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