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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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