Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
FDA device recall Z-0923-2026 · posted 2025-12-22 · Open, Classified
Recall details
- Recalling firm
- AGFA Healthcare Corp.
- 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.
- Action taken
- AGFA NV notified Customers via a letter titled "IMPORTANT PRODUCT INFORMATION LETTER / DR 800", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: "Always enable ABS for pulsed fluoro exams. Actions being taken by the manufacturer: Agfa/local business partner will contact you to install a new generator software."
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- IZF
- Quantity affected
- 35
- Distribution
- U.S. Nationwide distribution.
- Date initiated
- 2025-11-18
- Date posted
- 2025-12-22
- Location
- Greenville, SC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |