Sensis Vibe System recall: Software Issue
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Why was Sensis Vibe System recalled?
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
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?
Serial Number 120019
- Product
- Sensis Vibe System, Model Number 11007642, with software version VD10B.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1
- Distribution
- The products were distributed to the following US states: NJ.
- Recall date
- March 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)