Agfa N.V.: DR 800 X-ray System Recalled Due to Potential Table Lever Chain Failure

Agency Publication Date: August 27, 2024

Summary

Agfa N.V. is recalling 141 units of the DR 800 Digital Radiography X-ray System because the front lever chain of the imaging table may fail. This recall affects various device serial numbers and table serial numbers manufactured in Belgium and distributed worldwide, including throughout the United States. If the chain fails, it could compromise the structural integrity or movement of the imaging table during medical procedures. Consumers should contact Agfa or their healthcare facility to determine if their specific unit is included in this voluntary recall and to arrange for necessary inspections or repairs.

Risk

The front lever chain of the DR 800 table can break or fail unexpectedly. This failure could cause the X-ray table to move unintentionally or lose support, potentially leading to patient or operator injury during a radiographic examination.

What You Should Do

Locate the Type and Serial Number on your DR 800 Digital Radiography X-ray System to see if it matches the affected list. This recall applies to Type No. 6010/200 with UDI-DI 05414904251805.
Check your Device Serial Number against the following affected units: 643, 763, 903, 915, 925, 930, 945, 948, 949, 969, 984, 990, 992, 1003, 1022, 1032, 1042, 1049, 1052, 1116, 1123, 1136, 1148, 1161, 1197, 1203, 1217, 1229, 1239, 1279, 1323, 1341, 1401, 1404, 1453, 1458, 1460, 1489, 1506, 1507, 1509, 1521, 1532, 1568, 1627, 1676, 1691, 1704, 1733, 1756, 1757, 1828, 1850, 1878, 1888, 1893, 1920, 1921, 1924, 1926, 1932, 1938, 1941, 1943, 1950, 1954, 1956, 1957, 2010, 2070, 2079, 2088, 2094, 2101, 2115, 2129, 2130, 2131, 2157, 2169, 2192, 2193, 2225, 2233, 2243, 2244, 2251, 2253, 2254, 2277, 2289, 2297, 2310, 2314, 2318, 2333, 2340, 2359, 2371, 2377, 2378, 2409, 2415, 2416, 2428, 2436, 2437, 2449, 2450, 2475, 2483, 2513, 2538, 2580, 2642, 2678, 2687, 2756, 2781, 2833, 2842, 2873, 2886, 2892, 2901, 2931, 2941, 2955, 2992, 3006, 3040, 3068, 3101, 3134, 3143, 3151, 3161, 3217.
Verify if your Table Serial Number is included in the recall list, which includes numbers ranging from 31908 to 53884 (refer to the full technical list provided to your facility).
Contact your local Agfa service representative or Agfa N.V. directly via the contact information provided in the initial email notification to schedule an inspection and any necessary hardware remediation.
Inform healthcare providers and technical staff at your facility about the potential for table chain failure and follow any interim safety instructions provided by the manufacturer.
For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer inspection and correction.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund or repair options.

Affected Products

Product: DR 800 Digital Radiography X-ray System

Model / REF:

Type No. 6010/200

UDI-DI: 05414904251805

Lot Numbers:

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95115

Status: Active

Manufacturer: Agfa N.V.

Sold By: Authorized medical device distributors; Agfa direct sales

Manufactured In: Belgium

Units Affected: 141 units

Distributed To: California, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Virginia, West Virginia, Wisconsin

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Summary

What You Should Do

Locate the Type and Serial Number on your DR 800 Digital Radiography X-ray System to see if it matches the affected list. This recall applies to Type No. 6010/200 with UDI-DI 05414904251805.

Check your Device Serial Number against the following affected units: 643, 763, 903, 915, 925, 930, 945, 948, 949, 969, 984, 990, 992, 1003, 1022, 1032, 1042, 1049, 1052, 1116, 1123, 1136, 1148, 1161, 1197, 1203, 1217, 1229, 1239, 1279, 1323, 1341, 1401, 1404, 1453, 1458, 1460, 1489, 1506, 1507, 1509, 1521, 1532, 1568, 1627, 1676, 1691, 1704, 1733, 1756, 1757, 1828, 1850, 1878, 1888, 1893, 1920, 1921, 1924, 1926, 1932, 1938, 1941, 1943, 1950, 1954, 1956, 1957, 2010, 2070, 2079, 2088, 2094, 2101, 2115, 2129, 2130, 2131, 2157, 2169, 2192, 2193, 2225, 2233, 2243, 2244, 2251, 2253, 2254, 2277, 2289, 2297, 2310, 2314, 2318, 2333, 2340, 2359, 2371, 2377, 2378, 2409, 2415, 2416, 2428, 2436, 2437, 2449, 2450, 2475, 2483, 2513, 2538, 2580, 2642, 2678, 2687, 2756, 2781, 2833, 2842, 2873, 2886, 2892, 2901, 2931, 2941, 2955, 2992, 3006, 3040, 3068, 3101, 3134, 3143, 3151, 3161, 3217.

Verify if your Table Serial Number is included in the recall list, which includes numbers ranging from 31908 to 53884 (refer to the full technical list provided to your facility).

Contact your local Agfa service representative or Agfa N.V. directly via the contact information provided in the initial email notification to schedule an inspection and any necessary hardware remediation.

Inform healthcare providers and technical staff at your facility about the potential for table chain failure and follow any interim safety instructions provided by the manufacturer.

For further information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: DR 800 Digital Radiography X-ray System

Model / REF:

Type No. 6010/200

UDI-DI: 05414904251805

Lot Numbers:

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95115

Status: Active

Manufacturer: Agfa N.V.

Sold By: Authorized medical device distributors; Agfa direct sales

Manufactured In: Belgium

Units Affected: 141 units

Distributed To: California, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, South Carolina, Virginia, West Virginia, Wisconsin