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DaCapo Frame anthracite 04563

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09008737045630 UDI-DIDate23 Sep 2014ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2356-2024 FDA Class II initiated 18 Apr 2024

    A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

  • 3 recalls, same reason

    • Terminated Z-2138-2019 FDA Class II initiated 16 Oct 2018 via P000025, on the same PMA
    • Terminated Z-2136-2019 FDA Class II initiated 16 Oct 2018 via P000025, on the same PMA
    • Terminated Z-2137-2019 FDA Class II initiated 16 Oct 2018 via P000025, on the same PMA

    Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
DaCapo Frame anthracite
Generic Name
Portable/mobile rechargeable battery pack
Model / Reference
04563
Primary DI / UDI-DI
09008737045630
PMA Number
FDA Product Code
MCM
GMDN Term
Portable/mobile rechargeable battery pack
Device Class
Class III
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: Portable/mobile rechargeable battery pack

Cleared under the same submission (P000025)

Show all (12)

Other devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

See all devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H. →

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No