Z-2138-2019 Class II Terminated
FDA device recall Z-2138-2019 was initiated by MED-EL Elektromedizinische Gereate, Gmbh on October 16, 2018 and is designated Class II. Reason for recall: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. The recall status is terminated (terminated May 22, 2020). Affected quantity: 1 device.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- October 16, 2018
- Termination Date
- May 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 device
Product Description
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Reason for Recall
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Distribution Pattern
Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.
Code Information
Serial Number 202001