Recall Z-2238-2019 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Spectrum Medical Ltd.
Quantum Pump Console
| Date | Aug 23, 2019 (initiated May 29, 2019) |
| Status | Terminated |
| Reason | Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. |
| Root cause | Software design |
| Action | 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, |
| Quantity | 108 units (8 US, 100 OUS) |
| Distribution | US distribution to NY, OH, VA, WA. International distribution to the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173834 | Quantum Pump Console Spectrum Medical , Ltd., May 25, 2018 |