Agfa N.V.: DR 800. Digital Radiography X-ray System.

Recall number

Z-2738-2024

Recalling firm

Agfa N.V.

Product

DR 800. Digital Radiography X-ray System.

Status

Open, Classified

Initiated

2024-07-29

Posted

2024-08-27

Terminated

not on file

Reason

Potential for the front lever chain of the DR 800 table to fail.

Root cause

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.

Quantity

141 units

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

K180589, K183275

PMA numbers

not on file

Product code

JAA

Firm FEI

3001556265

Firm city

Mortsel

Firm state

not on file

Firm country

Belgium

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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