Cygnus, LLC
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Cygnus, LLC makes
Cygnus, LLC manufactures the Cygnus 12-lead ECG module, a device designed for electrocardiogram monitoring to capture and display heart electrical activity across multiple leads.
The company’s product portfolio is regulated under FDA Class II and requires 510(k) clearance. The device is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Cygnus 12 Lead Ecg Module Ref K072950
510(k) 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Cygnus, LLC, the earliest on 2005-02-04 and the most recent on 2005-09-08. By recorded status: 2 terminated. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 8 Sep 2005 Z-0564-06 Unclassified (pre-2012) Terminated When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
Full distribution text
- 4 Feb 2005 Z-0563-06 Unclassified (pre-2012) Terminated The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.
Full distribution text
- 8 Sep 2005 Z-0564-06 Unclassified (pre-2012) Terminated When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
Frequently asked questions
How many devices does Cygnus, LLC have in the registry?
The registry currently lists 1 device for Cygnus, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cygnus, LLC's devices?
Among its 1 most recently registered device, Cygnus, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Cygnus, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cygnus, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cygnus, LLC?
FDA recall records list 2 recalls initiated by Cygnus, LLC, the most recent initiated on 2005-09-08. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cygnus, LLC in the registry?
The most recently registered devices listed for Cygnus, LLC include CYGNUS 12 LEAD ECG MODULE.