# FDA recall Z-2238-2019

> **Spectrum Medical Ltd.** · Class I · device recall initiated 2019-05-29.

## Product

Quantum Pump Console

## Reason for recall

Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

## Distribution

US distribution to NY, OH, VA, WA.      International distribution to the Netherlands.

## Key facts

- **Recall number:** Z-2238-2019
- **Recalling firm:** Spectrum Medical Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-29
- **Report date:** 2019-09-04
- **Termination date:** 2020-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gloucester, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2019

## Citation

> AI Analytics. FDA recall Z-2238-2019. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2238-2019. Source: US FDA. Licensed CC0.

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