Z-2525-2018Class II

AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed...

Name: Z-2525-2018 AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-05-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-05-25 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and... on 2018-05-25. FDA classified it as Class II and gives the reason as "Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2525-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-25
Posted: 2018-07-20
Terminated: 2019-05-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens issued on May 25, 2018 an URGENT: MEDICAL DEVICE CORRECTION customer notification to affected customers and advised a hardware update will be initiated . Users advised of the problem, potential risks and action to be taken. Siemens will correct the error by replacing all affected cooling units with Update Instruction AX076/17/S. Users may continue to use the Artis system while awaiting implementation of the corrective action.
Quantity in commerce: 6 units US
Distribution: HI , IL, MI, NC, NY, VA, WI
Product codes and lots: Laird Cooling Unit for SSFD: Material # 7555118.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2525-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2525-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20
Z-2526-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-01	2018-07-20

Product code JAA

K021021Class IIModular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. / cleared 2002-06-06

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)