Z-2238-2019 Class I Terminated
FDA device recall Z-2238-2019 was initiated by Spectrum Medical Ltd. on May 29, 2019 and is designated Class I. Reason for recall: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. The recall status is terminated (terminated August 21, 2020). Affected quantity: 108 units (8 US, 100 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2019
- Initiation Date
- May 29, 2019
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 units (8 US, 100 OUS)
Product Description
Quantum Pump Console
Reason for Recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Distribution Pattern
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
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