# FDA recall Z-0923-2026

> **AGFA Healthcare Corp.** · Class II · device recall initiated 2025-11-18.

## 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.

## Distribution

U.S. Nationwide distribution.

## Key facts

- **Recall number:** Z-0923-2026
- **Recalling firm:** AGFA Healthcare Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-18
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Greenville, SC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2026

## Citation

> AI Analytics. FDA recall Z-0923-2026. Retrieved 2026-08-21 from https://api.ai-analytics.org/recall/Z-0923-2026. Source: US FDA. Licensed CC0.

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