DR 800. Digital Radiography X-ray System.
Enforcement
- Recall Number
- Z-2738-2024
- Event ID
- 95115
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Agfa N.V.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 4, 2024
- Initiation Date
- July 29, 2024
- Classification Date
- August 27, 2024
- Address
- Septestraat 27, Mortsel, N/A, Belgium
Description
DR 800. Digital Radiography X-ray System.
Potential for the front lever chain of the DR 800 table to fail.
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.
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.
141 units