FDA recall Z-2238-2019
Spectrum Medical Ltd. · Class I · device
Product
Quantum Pump Console
Reason for recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Distribution
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Key facts
- Status
- Terminated
- Initiation date
- 2019-05-29
- Report date
- 2019-09-04
- Termination date
- 2020-08-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Gloucester, N/A, United Kingdom
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2019