FDA recall Z-2525-2018

Product

AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.

Reason for recall

Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure

Distribution

HI , IL, MI, NC, NY, VA, WI

Key facts

Status

Terminated

Initiation date

2018-05-25

Report date

2018-08-01

Termination date

2019-05-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2018