Devices

Device Recall Cyberonics VNS Therapy Programming M250 System

Model / Serial
Model 250, VNS Therapy Programming M250 Programming System, version 4.6, 6.1, 7.0 or 7.1 labeling
Product Classification
Neurological Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide: USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product Description
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes or pre-installed on handheld computers.
Manufacturer
Cyberonics, Inc
1 Event
- Recall of Device Recall Cyberonics VNS Therapy Programming M250 System

Manufacturer

Cyberonics, Inc

Manufacturer Address
Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
Manufacturer Parent Company (2017)
LivaNova PLC
Source
USFDA

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