Recall Z-2342-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2342-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-29

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-06-29, terminated 2016-12-07. It names one FDA 510(k) clearance: K010721. Product: Axiom Artis systems, 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.. Reason: The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Terminated: 2016-12-07
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K010721 — AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMSiemens Medical Corp.·cleared 2001-03-30

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

Axiom Artis systems, 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Reason for recall

The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.

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