FDA Medical devices recall ·
AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common… recall
- Recall number
- Z-0923-2026
- Date
- (initiated November 18, 2025)
- Company / brand
- AGFA Healthcare Corp.
10 S Academy St, Greenville, SC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
N/A
Distribution
U.S. Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0923-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.