FDA recall Z-2793-2020

Brainlab AG · Class II · device

Product

BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

Reason for recall

Incorrect manufacturer calibration

Distribution

USA: CA, TX, RI OUS: Armenia; Australia; Brazil; Bulgaria; Canada; Finland; France; Germany; Hong Kong; India; Israel; Italy; Japan; Mongolia; Morocco; Spain

Key facts

Status: Terminated
Initiation date: 2020-07-16
Report date: 2020-08-19
Termination date: 2021-07-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Munich, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2793-2020