{ "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": "190585", "product_res_number": "Z-0355-2022", "event_date_initiated": "2021-11-12", "event_date_created": "2021-12-09", "recall_status": "Open, Classified", "res_event_number": "89129", "product_code": "OWB", "k_numbers": [ "K010435" ], "product_description": "BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system.\nModel Number: 718075", "code_info": "Serial Number:\n173\n105\n5301\n4950\n5360\n4651\n4891\n873\n1633\n160\n543\n562\n204\n5090\n5091\n5092\n4840\n5073\n125\n383\n384\n5121\n\nUDI:\n(01)00884838055490(21)173\n(01)00884838055490(21)105\n(01)00884838055490(21)5301\n(01)00884838055490(21)4950\n(01)00884838055490(21)5360\n(01)00884838055490(21)4651\n(01)00884838055490(21)4891\n(01)00884838055490(21)873\n(01)00884838055490(21)1633\n(01)00884838055490(21)160\n(01)00884838055490(21)543\n(01)00884838055490(21)562\n(01)00884838055490(21)204\n(01)00884838055490(21)5090\n(01)00884838055490(21)5091\n(01)00884838055490(21)5092\n(01)00884838055490(21)4840\n(01)00884838055490(21)5073\n(01)00884838055490(21)125\n(01)00884838055490(21)383\n(01)00884838055490(21)384\n(01)00884838055490(21)5121", "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": "Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns", "root_cause_description": "Device Design", "action": "Philips issued an Urgent Medical Device Correction letter in the USA on 11/12/21 via Certified mailing United States Postal Service. Recalling outside the US is done through the local Philips organizations in the respective countries\nLetter states reason for recall, health risk and action to take:\nPay attention to the Heat Indication Level Icons shown in the Viewing Station to know the temperature of the X-Ray Tank.\no Follow the instructions provided in Annex I of this letter for a safe use of the system.\no Circulate this notice to all users of this device so that they are aware of the issue.\no Place this Field safety Notice with the documentation of the of your system\no Transfer this Field Safety notice within your organization or to any organization, if the affected devices have been transferred.\no Complete the enclosed Customer Reply Form and send it back to confirm that users have reviewed and understood this Urgent Field Safety Notice.\n5. Actions planned by Philips IGT Systems to correct the problem\nPhilips is informing customers through this Urgent Field Safety Notice and providing the Addendum to the Instructions For Use of the BV Endura Release 2.3, BV Pulsera Release 2.3 and Veradius Unity Release 2.1 systems.", "product_quantity": "22 units US", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, \nKazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic, \nLatvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives\nMali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, \nNamibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, \nPalestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, \nPuerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia, \nSenegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan,\nSweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, \nUkraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, \nViet Nam, Yemen, Zambia, Zimbabwe.", "openfda": { "k_number": [ "K201583", "K201172", "K223409", "K002198", "K002016", "K152928", "K092439", "K200218", "K093066", "K191503", "K100102", "K142273", "K201743", "K070123", "K121444", "K162614", "K172180", "K133819", "K203281", "K160455", "K260607", "K153232", 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