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

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)! 

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.