Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA… — Class II medical device recall Z-0923-2026
Ongoing recall by AGFA Healthcare Corp., reported 2025-12-31, distributed nationwide. It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This c
| Recall number | Z-0923-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | AGFA Healthcare Corp., Greenville, SC, United States |
| Recall initiated | 2025-11-18 |
| Classified | 2025-12-22 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 35 |
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Reason for recall
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.
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-0923-2026. 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.