Class II — Agfa N.V.
| Recalling firm | Agfa N.V. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for the front lever chain of the DR 800 table to fail. |
| Product | DR 800. Digital Radiography X-ray System. |
| Quantity | 141 units |
| 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. |
| Initiated | 2024-07-29 |
| Classified | 2024-08-27 |
| Recall number | Z-2738-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Agfa N.V. (Z-2738-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95115/
Alerts for Agfa N.V.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.