[pending] Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Pending LLM rewrite. Source: FDA_DEVICE Z-0923-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
- Manufacturer
- AGFA Healthcare Corp.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- N/A
Distribution
Distributed nationwide across the United States.
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