Recall – Pump console shuts down during use, CL I

Company: Spectrum Medical Ltd.
Date of Enforcement Report: 9/4/2019
Class I

PRODUCT

Quantum Pump Console

  • Recall Number: Z-2238-2019

REASON

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

RECALLING FIRM/MANUFACTURER

Spectrum Medical Ltd. on 5/29/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

104 units (8 US, 96 OUS)

DISTRIBUTION

US Nationwide and the Netherlands

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