# FDA recall Z-1034-2019

> **Agfa N.V.** · Class III · device recall initiated 2019-01-25.

## Product

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film  REF:   XJUB8, XJM73,  XJUDD, XJM85, EKLYZ. Product Usage:    Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

## Reason for recall

Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

## Distribution

US nationwide distribution in the state of OH.

## Key facts

- **Recall number:** Z-1034-2019
- **Recalling firm:** Agfa N.V.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-25
- **Report date:** 2019-03-27
- **Termination date:** 2019-06-14

- **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-1034-2019

## Citation

> AI Analytics. FDA recall Z-1034-2019. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-1034-2019. Source: US FDA. Licensed CC0.

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