DR 800. Digital Radiography X-ray System recallZ-2738-2024 · Agfa N.V. · initiated Jul 29, 2024
Class II Open, Classified All recalls posted in August 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Agfa N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the front lever chain of the DR 800 table to fail.
FDA root cause category: Device Design
What the company is doing
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 [email protected]. Consignees with any questions are to call 1-877-777-2432 and reference PRB2001106.
Recall details
- Recall number
- Z-2738-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 29, 2024
- Posted by the FDA
- Aug 27, 2024
- Recalling firm
- Agfa N.V.
- Quantity
- 141 units
- Product code
- JAA
- FDA submissions
- K180589, K183275
- 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.
Product description
DR 800. Digital Radiography X-ray System.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DR 800 6010/200Agfa · System, x-ray, fluoroscopic, image-intensified1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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