Quantum Pump Console
- Company
- Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom
- Recall Initiated
- May 29, 2019
- Posted
- August 23, 2019
- Terminated
- August 21, 2020
- Recall Number
- Z-2238-2019
- Quantity
- 108 units (8 US, 100 OUS)
Reason for Recall
Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
Distribution
US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
Lot / Code Info
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
Root Cause
Software design
Action Taken
Spectrum Medical notified customers on about 05/29/2019 via "URGENT FIELD SAFETY CORRECTION" letter. Customers were informed that Spectrum Medical is in the process of installing the most recent software update v6.2.3.16 to the Quantum Perfusion Systems, (Quantum Pump Console). This software update corrects an error that could potentially lead to power loss. All Quantum Perfusion Systems are in scope of this issue. Customers were instructed to be aware that user intervention may be necessary with continued use before the software update, assure that all users receive notice of this issue, confirm receipt of the Urgent Medical Device Correction by returning the customer response form, and a Spectrum Medical service team will contact each customer and arrange a time and date to update the systems with the most recent software update. Additionally, customers were instructed to notify all relevant personnel and to customers if the devices have been further distributed.