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Liberta RC™ 62400

by Advanced Neuromodulation Systems

Part of a family of 23 devices: see the family page

Ref 62400

Liberta RC™ 62400 is a Class III device made by Advanced Neuromodulation Systems, registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 5415067DBS0001BQ) with CE/MDR certificate MDR 744775 valid until 19 Dec 2026, approved under FDA PMA P140009 on 12 Jun 2015 and listed in FDA GUDID since 16 Feb 2024 (UDI-DI 05415067047663), active as of 25 Oct 2026. 5 FDA recalls are linked to it.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

19 Dec 2026

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

2 certificates

Certifier BSI Group The Netherlands B.V.

PMA P140009

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067DBS0001BQ Basic UDI-DI 05415067047663UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067047663 UDI-DI Date16 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP140009 Date12 Jun 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067DBS0001BQ registered 13 Aug 2026 Active· +1 more in the status table
  • FDA PMA P140009 decided 12 Jun 2015 Active
  • FDA GUDID UDI-DI 05415067047663 listed 16 Feb 2024 Listed

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 744775 Expiring Supplemented Expires in 37 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Aug 2026
    Expires
    19 Dec 2026
    Reason
    Other
  • MDR 744775 Expiring Supplemented Expires in 37 days Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Aug 2026
    Expires
    19 Dec 2026
    Reason
    Other

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-0459-2026 FDA Class II initiated 6 Oct 2025

    There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

  • 4 recalls, same reason

    • Terminated Z-2696-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2693-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2695-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2694-2017 FDA Class II initiated 2 Jun 2017

    The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

Timeline

10 dated events

  1. Approved FDA PMA P140009
  2. Recall initiated FDA recalls Z-2696-2017
  3. Recall initiated FDA recalls Z-2693-2017
  4. Recall initiated FDA recalls Z-2695-2017
  5. Recall initiated FDA recalls Z-2694-2017
  6. Listed FDA GUDID 05415067047663
  7. Recall initiated FDA recalls Z-0459-2026
  8. Certificate issued EUDAMED MDR 744775
  9. Registered EUDAMED 5415067DBS0001BQ
  10. Certificate expires EUDAMED MDR 744775

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Liberta RC™
Generic name
Deep brain electrical stimulation system
Device name
Deep Brain Stimulation
Model / Ref / Catalog
62400
Primary DI / UDI-DI
05415067047663
Basic UDI-DI
5415067DBS0001BQ
PMA number
FDA product code
PJS, NHL, MHY
EMDN code
J02010101 Deep brain stimulation (dbs) implantable neurostimulators, rechargeable
GMDN term
Deep brain electrical stimulation system
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Deep brain electrical stimulation system

Cleared under the same submission (P140009)

and 8 more cleared under P140009

Similar devices in this category

Other devices filed under IMPLANTABLE NEUROSTIMULATORS.

Other devices from Advanced Neuromodulation Systems

  • MN13650

    Class III

  • 1210 Open recall

    Class III

  • Infinity™ 6884 Open recall

    Class III

  • Proclaim™ 3884 Open recall

    Class III

See all devices from Advanced Neuromodulation Systems →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (19, all answered No)