Recall Z-0108-2021— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0108-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-03

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-08-03, terminated 2021-02-03. It names one FDA 510(k) clearance: K181407. Product: Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959. Reason: Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-08-03
Terminated: 2021-02-03
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181407 — Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc.·cleared 2018-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

Reason for recall

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Data sourced from openFDA. This site is unofficial and independent of the FDA.