FDA recall Z-2524-2018

Product

ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000

Reason for recall

During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).

Distribution

The devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.

Key facts

Status

Terminated

Initiation date

2018-05-30

Report date

2018-08-01

Termination date

2020-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2524-2018