# FDA recall Z-2202-2020

> **Agfa N.V.** · Class II · device recall initiated 2020-04-06.

## Product

AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following 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

Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible

## Distribution

US Nationwide distribution including in the sates of FL, IL, IN, LA, MA, MO, OH, SC, VA, WI.

## Key facts

- **Recall number:** Z-2202-2020
- **Recalling firm:** Agfa N.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-06
- **Report date:** 2020-06-10
- **Termination date:** 2023-04-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2020

## Citation

> AI Analytics. FDA recall Z-2202-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-2202-2020. Source: US FDA. Licensed CC0.

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