Class II

Medical Device Recall: DR 800. Digital Radiography X-ray System.

Agfa N.V. · July 29, 2024

Reason for Recall

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

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.

States Affected

NATIONWIDE

Quantity Affected

141 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2738-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.