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Recall Observatory FDA recall evidence

Device product

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

Z-0913-2023

December 03, 2022

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 91296
Status
Ongoing
Classification
Class II
Quantity
18 units
Official record key
device-enforcement:Z-0913-2023

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 00643169890961: Lot/Serial Numbers: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, NPL1000429,

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software anomalies