Z-2738-2024 Class II Ongoing
FDA device recall Z-2738-2024 was initiated by Agfa N.V. on July 29, 2024 and is designated Class II. Reason for recall: Potential for the front lever chain of the DR 800 table to fail. The recall status is ongoing. Affected quantity: 141 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- July 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 units
Product Description
DR 800. Digital Radiography X-ray System.
Reason for Recall
Potential for the front lever chain of the DR 800 table to fail.
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.
Code Information
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.