Quantum Pump Console
FDA device recall Z-2238-2019 · posted 2019-08-23 · Terminated
Recall details
- Recalling firm
- Spectrum Medical Ltd.
- Reason for recall
- Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DTQ
- Quantity affected
- 108 units (8 US, 100 OUS)
- Distribution
- US distribution to NY, OH, VA, WA. International distribution to the Netherlands.
- Date initiated
- 2019-05-29
- Date posted
- 2019-08-23
- Date terminated
- 2020-08-21
- Location
- Gloucester, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |