Medical device recalls Moderate risk

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

Recall date
July 29, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2738-2024
FDA classification
Class II
Brand / firm
Agfa N.V.
Sold / distributed
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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DR 800. Digital Radiography X-ray System.

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