Spectrum Medical Recalls Quantum Pump Consoles Due to Shutdown Risk
Spectrum Medical Ltd. is recalling 108 Quantum Pump Consoles because they may unexpectedly shut down while in use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (unexpected shutdown) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Spectrum Medical Ltd. is recalling 108 units of the Quantum Pump Console, which is part of the Quantum Perfusion Systems. The recall involves software version 6.2.1.9 and specific serial numbers listed in the agency documentation.
The recall is being conducted because the devices have the potential to unexpectedly shut down while in use. This defect could interrupt the intended function of the perfusion system during a medical procedure.
The affected units were distributed in the United States to New York, Ohio, Virginia, and Washington, as well as internationally to the Netherlands. Users of these devices should contact Spectrum Medical Ltd. for further instructions on how to resolve the issue.
The recalled product
- Product
- Quantum Pump Console
- Manufacturer
- Spectrum Medical Ltd.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Software version 6.2.1.9
- Serial Numbers PH1000005
- PH1000020
- PH1000027
- PH1000030
- PH1000077
- PH1000081
- PH1000082
- PH1000086
- PH1000087
- PH1000093
- PH1000100
- PH1000101
- PH1000102
- PH1000103
- PH1000109
- PH1000110
- PH1000112
- PH1000113
- PH1000114
Distribution
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