Reported Sep 4, 2019 · Terminated
Quantum Pump Console
Spectrum Medical Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectrum Medical Ltd. · Harrier 4, Meteor Business Park · Gloucester, N/A · N/A
Is this the product you have?
- Quantum Pump Console
- Lot codes and dates
109 of 109 codes
Software version 6.2.1.9Serial Numbers PH1000005PH1000020PH1000027PH1000030PH1000077PH1000081PH1000082PH1000086PH1000087PH1000093PH1000100PH1000101PH1000102PH1000103PH1000109PH1000110PH1000112PH1000113PH1000114PH1000115PH1000120PH1000127PH1000129PH1000131PH1000132PH1000134PH1000135PH1000137PH1000139PH1000140PH1000141PH1000144PH1000145PH1000150PH1000156PH1000158PH1000159PH1000160PH1000161PH1000162PH1000165PH1000168PH1000170PH1000171PH1000172PH1000175PH1000176PH1000177PH1000178PH1000179PH1000180PH1000182PH1000201PH1000208PH1000209PH1000210PH1000211PH1000212PH1000213
- Amount recalled
- 108 units (8 US, 100 OUS)
Where it was sold
Why it was recalled
Stop using this product now
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Using this product could cause serious injury, illness or death — stop using it now.
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