PlainRecalls
FDA Devices Moderate Class II Terminated

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

Reported: March 3, 2021 Initiated: December 18, 2020 #Z-1144-2021

Product Description

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.

Reason for Recall

Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system

Details

Units Affected
41 U.S
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 41 U.S.
Why was this product recalled?
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
Which agency issued this recall?
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1144-2021.