Recall Z-2738-2024— Agfa N.V.

Name: FDA recall Z-2738-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-29

Class II · Ongoing

Class II FDA medical device recall by Agfa N.V., initiated 2024-07-29. It names 2 FDA 510(k) clearances: K183275, K180589. Product: DR 800. Digital Radiography X-ray System.. Reason: Potential for the front lever chain of the DR 800 table to fail..

Recalling firm: Agfa N.V.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-29
Firm location: Mortsel, Belgium

510(k) clearances named in this recall

2 on FDA's record

K183275 — DR 800 with TomosynthesisAgfa N.V.·cleared 2019-02-01
K180589 — DR 800 with MUSICA DynamicAgfa Healthcare N.V.·cleared 2018-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DR 800. Digital Radiography X-ray System.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.