VNS(R) Therapy Programmer recall: Software Issue
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy…
Why was VNS(R) Therapy Programmer recalled?
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
- Product
- VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy…
- Recalling firm
- Cyberonics, Inc
- Quantity
- 2 units
- Distribution
- US Distribution to the states of : CO and ND
- Recall date
- February 14, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)