Z-1150-2018Class II

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of...

Name: Z-1150-2018 AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-01-05
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-01-05 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis is a family of dedicated angiography systems developed for single... on 2018-01-05. FDA classified it as Class II and gives the reason as "Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or...". 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-1150-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-05
Posted: 2018-03-20
Terminated: 2018-08-23
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Artis 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Siemens Healthineers, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 1/5/2018 to its consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to follow their standard emergency procedures in place in the event of system failures; to consider reinforcing these emergency procedures until the update has been completed. Siemens will replace all affected plastic couplings with metal couplings. The Siemens service organization will contact the consignees to arrange a date to perform this corrective action.If the device has been sold and is therefore no longer in your possession, please forward this field correction notice to the new owner. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 22
Distribution: US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
Product codes and lots: Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1150-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1150-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-21

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)