DR 800 — Class II medical device recall Z-2738-2024
Ongoing recall by Agfa N.V., reported 2024-09-04, distributed nationwide. Potential for the front lever chain of the DR 800 table to fail.
| Recall number | Z-2738-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa N.V., Mortsel, Belgium |
| Recall initiated | 2024-07-29 |
| Classified | 2024-08-27 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 141 units |
| UPC / GTIN / UDI-DI | 05414904251805 |
| Serial numbers | 1003, 1022, 1032, 1042, 1049, 1052, 1116, 1123, 1136, 1148, 1161, 1197, 1203, 1217, 1229, 1239, 1279, 1323, 1341, 1401, 1404, 1453, 1458, 1460, 1489 and 254 more |
Product
DR 800. Digital Radiography X-ray System.
Reason for recall
Potential for the front lever chain of the DR 800 table to fail.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2738-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.