# FDA recall Z-1954-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-06-20.

## Product

Cios care fusion system

## Reason for recall

DAP chamber may be missing an insulating foil

## Distribution

IL, NE

## Key facts

- **Recall number:** Z-1954-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-20
- **Report date:** 2019-07-17
- **Termination date:** 2020-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1954-2019

## Citation

> AI Analytics. FDA recall Z-1954-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1954-2019. Source: US FDA. Licensed CC0.

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