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 6.2.1.9
    • Serial Numbers PH1000005
    • PH1000020
    • PH1000027
    • PH1000030
    • PH1000077
    • PH1000081
    • PH1000082
    • PH1000086
    • PH1000087
    • PH1000093
    • PH1000100
    • PH1000101
    • PH1000102
    • PH1000103
    • PH1000109
    • PH1000110
    • PH1000112
    • PH1000113
    • PH1000114
    • PH1000115
    • PH1000120
    • PH1000127
    • PH1000129
    • PH1000131
    • PH1000132
    • PH1000134
    • PH1000135
    • PH1000137
    • PH1000139
    • PH1000140
    • PH1000141
    • PH1000144
    • PH1000145
    • PH1000150
    • PH1000156
    • PH1000158
    • PH1000159
    • PH1000160
    • PH1000161
    • PH1000162
    • PH1000165
    • PH1000168
    • PH1000170
    • PH1000171
    • PH1000172
    • PH1000175
    • PH1000176
    • PH1000177
    • PH1000178
    • PH1000179
    • PH1000180
    • PH1000182
    • PH1000201
    • PH1000208
    • PH1000209
    • PH1000210
    • PH1000211
    • PH1000212
    • PH1000213
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2020 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.