FDA recall Z-2442-2020

Product

Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887

Reason for recall

The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.

Distribution

MA, IL, NH, NC, UT, OH, FL, MN, TX, NY, LA, AZ, MT, WV, Austria, Croatia, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lithuania, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, United Kingdom

Key facts

Status

Terminated

Initiation date

2020-06-10

Report date

2020-07-08

Termination date

2024-08-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2442-2020