FDA recall Z-0638-2018

Product

ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.

Reason for recall

Robot arm being sent to the wrong position

Distribution

Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.

Key facts

Status

Terminated

Initiation date

2017-05-01

Report date

2018-02-28

Termination date

2020-07-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0638-2018