# FDA recall Z-2056-2019

> **Agfa N.V.** · Class II · device recall initiated 2019-06-27.

## Product

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic    Product Usage:  The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following an anatomies/procedures: positioning fluoroscopy procedures, gastro-intestinal examinations, urogenital tract examinations, and angiography. It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for mammography applications.

## Reason for recall

The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2056-2019
- **Recalling firm:** Agfa N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-27
- **Report date:** 2019-08-07
- **Termination date:** 2020-06-03

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Mortsel, N/A, Belgium

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2056-2019

## Citation

> AI Analytics. FDA recall Z-2056-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2056-2019. Source: US FDA. Licensed CC0.

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