Recall Z-1341-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1341-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-09

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-04-09, terminated 2020-04-23. It names one FDA 510(k) clearance: K123529. Product: Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.. Reason: In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-04-09
Terminated: 2020-04-23
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2013-02-26

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 Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

Reason for recall

In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.

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