Z-0927-2012

AXIOM Artis and AXIOM Artis zee modular angiographic systems

Name: Z-0927-2012 AXIOM Artis and AXIOM Artis zee modular angiographic systems
Creator: Siemens Medical Solutions USA, Inc
Published: 2012-01-16
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2012-01-16 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems on 2012-01-16. The reason FDA records is "There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0927-2012
Status: Terminated
Initiated: 2012-01-16
Posted: 2012-01-27
Terminated: 2014-01-31
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. This is not a general issue but sporadic as a vendor unsystematical
Root cause tag: software
FDA root cause: Software change control
Action: Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.
Quantity in commerce: 45
Distribution: Nationwide Distribution (USA) including the states of: CA, CT, FL, GA, HI, IL, IN, KY, ME, MD, MI, MS, MO, NH, NJ, NY, NC, OH, OR, TN, TX, UT, VA, WI and Puerto Rico.
Product codes and lots: Model numbers 5904433, 5904441, 5904649, 5904656, 5904466, 7007755, 7728350, 7412807, 7727717, 7728392, 7413078, 7555373, 7555365, 7555357, 7008605, 5917054, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959.

Product code JAA

K052202Class IIAxiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2006-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)