Product Wiki · Recalls · U.S. FDA — Device Enforcement

MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PI — recall Z-2136-2019

U.S. FDA — Device Enforcement · Austria · 2018-10-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2136-2019
Date of alert
2018-10-16
Country / jurisdiction
Austria
Risk level
Class II
Risk type
recall
Brand
MED-EL Elektromedizinische Gereate, Gmbh
Product category
device
Product type
Devices
Reported risk: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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