{ "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": 4 } }, "results": [ { "cfres_id": "124413", "product_res_number": "Z-0545-2014", "event_date_initiated": "2013-11-05", "event_date_posted": "2013-12-19", "recall_status": "Terminated", "event_date_terminated": "2014-08-11", "res_event_number": "66983", "product_code": "EIA", "k_numbers": [ "K974487" ], "product_description": "SEAC Advanced Dental System, Model A591561\n\nThe SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.", "code_info": "Code No: 2010, 2020,2120 and 2220 Serial No: 590341- 592066", "firm_fei_number": "1000160293", "recalling_firm": "ASI Medical, Inc.", "address_1": "14550 E Easter Ave Ste 700 14550 E Easter Ave", "address_2": "Ste 700", "city": "Centennial", "state": "CO", "postal_code": "80112-4271", "additional_info_contact": "Amy H Nguyen \n303-766-3646", "reason_for_recall": "ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.", "root_cause_description": "Device Design", "action": "ASI Medical sent an Field Correction Action and Safety Notice letter dated November 5, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.\n\nREQUIRED FIELD CORRECTION\nOur field correction will consist of sending you a warning label to be applied to the back service access panel of the cart and an ASME safety pop off valve that will open and exhaust if pressure should reach over 100 psi. This safety pop off valve is designed be easily installed in line between the air compressor and air tank in your system. We are requesting your cooperation in making this field correction.", "product_quantity": "337", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including the countries of Austria, Aruba, Saudi Arabia, Canada, Germany, Spain and West Indies.", "openfda": { "k_number": [ "K211556", "K781882", "K933165", "K973996", "K973035", "K991161", "K051657", "K932878", "K951019", "K973765", "K922985", "K991946", "K242404", "K903453", "K000577", "K981663", "K983739", "K883904", "K990948", "K132315", "K790112", "K112321", "K240754", "K891006", "K885299", "K974542", "K983242", "K983625", "K970626", "K854642", "K901672", "K120239", "K001541", "K930144", "K031681", "K231845", "K970002", "K251491", "K884219", "K982480", "K964271", "K911594", "K082985", "K101332", "K150490", "K781114", "K973492", "K983731", "K980577", "K984609", "K983847", "K771890", "K052470", "K023513", "K032070", "K963778", "K934815", "K141504", "K991035", "K905011", "K992893", "K103550", "K973410", "K001445", 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