Recall MonitorHealth Products
Vanta/Sequentia Lt Clinician Programmer Application
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Vanta/Sequentia Lt Clinician Programmer Application
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Vanta/Sequentia Lt Clinician Programmer Application | More than 10 numbers, contact manufacturer. | A71200 |
Issue
The Vanta A71200 CP app V2.0.2465 and V2.0.2683 will display a "system error" if the user selects the start usage button twice when interrogating a new implantable neurostimulator (INS). This error prompts the user to restart the CP app and contact Medtronic for assistance. Upon subsequent interrogation of the INS, the Vanta A71200 CP app will display a "validation error" prompting the user to resolve the error in order to proceed with the INS interrogation. If the validation error is not resolved, the user is unable to complete the first attempt at interrogating the INS.