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Recall Observatory FDA recall evidence

Device product

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

Z-0915-2023

December 03, 2022

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 91296
Status
Ongoing
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-0915-2023

Official wording

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

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

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software anomalies