Device product
Quantum Pump Console
Z-2238-2019
Product summary
- 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
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.