FDA-Device2019-09-04Class I
Quantum Pump Console
Spectrum Medical Ltd.
Hazard
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Sold states
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Affected count
108 units (8 US, 100 OUS)
Manufactured in
Harrier 4, Meteor Business Park, Cheltenham Road East, Gloucester, N/A, United Kingdom
Products
Quantum Pump Console
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief