{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "209480", "product_res_number": "Z-2738-2024", "event_date_initiated": "2024-07-29", "event_date_posted": "2024-08-27", "recall_status": "Open, Classified", "res_event_number": "95115", "product_code": "JAA", "k_numbers": [ "K180589", "K183275" ], "product_description": "DR 800. Digital Radiography X-ray System.", "code_info": "Type No. 6010/200; UDI-DI: 05414904251805; Device Serial No. 925, 945, 948, 949, 990, 1003, 1022, 1116, 1136, 1161, 1229, 1239, 1401, 1404, 1453, 1460, 1489, 1506, 1532, 1568, 1704, 1733, 1757, 1888, 1893, 1950, 1954, 1957, 2010, 2070, 2130, 2244, 2297, 2371, 2378, 2901, 2931, 3068, 3217, 1507, 643, 763, 903, 915, 930, 969, 984, 992, 1032, 1042, 1049, 1052, 1123, 1148, 1197, 1217, 1323, 1341, 1203, 1279, 1458, 1509, 1521, 1627, 1676, 1691, 1756, 1828, 1850, 1878, 1921, 1924, 1926, 1932, 1938, 1941, 1943, 1956, 2079, 2088, 2094, 2101, 2115, 2129, 2131, 2157, 2169, 2192, 2193, 2225, 2233, 2243, 2251, 2253, 2254, 2277, 2289, 2310, 2314, 2318, 2333, 2340, 2359, 2377, 2409, 2415, 2416, 2428, 2436, 2437, 2449, 2450, 2475, 2483, 2513, 2538, 2580, 2642, 2678, 2687, 2756, 2781, 2833, 2842, 2873, 2886, 2892, 2941, 2955, 2992, 3101, 3134, 3143, 3151, 3161, 1920, 3006, 3040; Table Serial No. 32497, 34673, 34695, 34713, 34717, 34976, 34990, 35350, 36241, 36267, 36462, 37150, 37177, 38592, 38595, 38624, 38648, 39729, 39763, 39773, 39796, 41160, 41179, 41192, 42084, 42088, 42139, 42138, 43208, 43239, 43250, 44203, 45270, 45274, 46108, 46130, 49894, 51360, 52275, 53884, 39755, 31908, 32486, 32977, 34257, 34353, 34355, 34678, 34957, 34970, 34979, 35365, 35371, 38591, 35756, 36246, 36442, 36883, 37137, 37869, 37909, 36889, 37221, 38630, 39739, 39757, 40634, 41132, 41147, 41191, 42066, 42071, 42076, 42098, 42101, 42102, 42113, 42115, 42117, 42118, 42140, 43259, 43265, 43269, 43288, 44180, 44188, 44192, 44212, 44233, 44253, 44254, 45219, 45227, 45235, 45259, 45249, 45264, 45260, 45269, 45282, 45283, 45285, 45299, 45304, 46076, 46113, 46145, 46148, 46156, 46166, 46167, 47188, 46175, 47186, 47204, 47207, 47227, 47241, 47273, 48349, 48361, 48376, 48413, 49808, 49830, 49834, 49869, 49882, 49887, 51364, 51381, 51422, 52303, 52322, 52327, 52333, 52337, 42097, 51428, 52255.", "firm_fei_number": "3001556265", "recalling_firm": "Agfa N.V.", "address_1": "Septestraat 27 27 septestraat", "city": "Mortsel", "country": "Belgium", "reason_for_recall": "Potential for the front lever chain of the DR 800 table to fail.", "root_cause_description": "Device Design", "action": "Consignees were sent an URGENT FIELD SAFETY NOTICE by email, dated 7/29/24. In the notice, consignees are asked to check the correct tightening of the floor plate fixing bolts if a high and persistent noise is heard from the device during the tilting or elevation movement of the tabletop. If the noise persists, the device must be stopped immediately in a horizontal position at the maximum height. Agfa will coordinate with consignees to schedule an inspection of affected devices and to install hardware intended to reinforce equipment before 10/15/24. The recall notification is to be shared within consignee organizations and forwarded to those devices were transferred to. Consignees are asked to maintain awareness of this notice until devices are corrected. Completed response forms are to be provided via email to cassandra.mcgowan@agfa.com. Consignees with any questions are to call 1-877-777-2432 and reference PRB2001106.", "product_quantity": "141 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, FL, IL, IN, KS, LA, MA, MO, NJ, NC, OH, OK, SC, VA, WV, WI; and the countries of AU, BE, BW, CA, CO, CZ, DE, ES, FR, GB, GR, IL, IN, IT, KZ, MX, PL, RS, UZ, ZA.", "openfda": { "k_number": [ "K982319", "K915592", "K943805", "K902927", "K801320", "K934626", "K896331", "K781711", "K954590", "K871911", "K200396", "K953974", "K925251", "K961207", "K051602", "K161019", "K922240", "K890745", "K151485", "K993038", "K945460", "K203087", "K061028", "K883372", "K901671", "K926122", "K934481", "K150306", "K173395", "K924164", "K855213", "K233380", "K895546", "K961140", "K820178", "K902981", "K081491", "K140380", "K961193", "K802953", "K953950", "K973744", "K904986", "K930885", "K810716", "K820184", "K050866", "K884598", "K950781", "K850959", "K232526", "K022565", "K936236", "K920721", "K770337", 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