Recall Z-0708-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0708-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-06

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-06-06, terminated 2019-05-16. It names one FDA 510(k) clearance: K052202. Product: Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392. Reason: Potential for liquid entry.

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Terminated: 2019-05-16
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K052202 — AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2006-03-07

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, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

Reason for recall

Potential for liquid entry

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