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Recall Observatory FDA recall evidence

Device product

Quantum Pump Console

Z-2238-2019

May 29, 2019

Class I

Product summary

Firm
Spectrum Medical Ltd.
Event
Event 83352
Status
Terminated
Classification
Class I
Quantity
108 units (8 US, 100 OUS)
Official record key
device-enforcement:Z-2238-2019

Official wording

Reason: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

Code information: 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, PH1000215, PH1000233, PH1000256, PH1000257, PH1000259, PH1000438, PH1000439, PH1000440, PH1000441, PH1000442, PH1000445, PH1000455, PH1000495, PH1000498, PH1000522, PH1000615, PH1000644, PH1000645, PH1000646, PH1000647, PH1000648, PH1000649, PH1000668, PH1000669, PH1000670, PH1000682, PH1000683, PH1000684, PH1000686, PH1000687, PH1000688, PH1000689, PH1000692, PH1000722, PH1000726, PH1000727, PH1000740, PH1000742, PH1000743, PH1000744, PH1000879, PH1000880, PH1000882, PH1000885, PH1000886, PH1000895, PH1000897, PH1000939, PH1000940

Distribution pattern: US distribution to NY, OH, VA, WA. International distribution to the Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.