Z-0555-2018 Class II Terminated
FDA device recall Z-0555-2018 was initiated by Cyberonics, Inc on December 2, 2017 and is designated Class II. Reason for recall: Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software. The recall status is terminated (terminated August 6, 2018). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- December 2, 2017
- Termination Date
- August 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Reason for Recall
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Distribution Pattern
US Distribution to the states of : CO and ND
Code Information
Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500