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