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Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Mo...

FDA Recall #Z-0915-2023 — Class II — December 3, 2022

Recall #Z-0915-2023 Date: December 3, 2022 Classification: Class II Status: Ongoing

Product Description

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

Reason for Recall

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Recalling Firm

Medtronic Neuromodulation — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

22 units

Distribution

Worldwide distribution.

Code Information

GTIN 00763000447090: Serial/Lot Numbers: NPL3022869, NPL3022873, NPL3022049, NPL3022050, NPL3022795, NPL3022817, NPL3022190, NPL3022191, NPL3022052, NPL3022187, NPL3022193, NPL3022194, NPL3022195, NPL3022212, NPL3022213, NPL3022289, NPL3021964, NPL3022043, NPL3022044, NPL3022034, NPL3021984, NPL3021990

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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