Agfa N.V.: Device Recall

Recall #Z-2738-2024 · 07/29/2024

Class II: Risk

Recall Details

Recall Number
Z-2738-2024
Classification
Class II
Product Type
Device
Recalling Firm
Agfa N.V.
Status
Ongoing
Date Initiated
07/29/2024
Location
Mortsel, Belgium
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
141 units

Reason for Recall

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

Product Description

DR 800. Digital Radiography X-ray System.

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.