Recall Z-0923-2026 ยท IZF System, X-Ray, Tomographic
AGFA Healthcare Corp.
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
| Date | Dec 22, 2025 (initiated Nov 18, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | 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." |
| Quantity | 35 |
| Distribution | U.S. Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183275 | DR 800 with Tomosynthesis Agfa N.V., Feb 1, 2019 |