PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: August 1, 2018 Initiated: May 25, 2018 #Z-2525-2018

Product Description

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

Details

Units Affected
6 units US
Distribution
HI , IL, MI, NC, NY, VA, WI
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6 units US.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2018. Severity: Moderate. Recall number: Z-2525-2018.