Z-3009-2011

Siemens Axiom Artis U mobile x-ray system

Name: Z-3009-2011 Siemens Axiom Artis U mobile x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2011-06-29
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2011-06-29 / Terminated / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system on 2011-06-29. The reason FDA records is "When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3009-2011
Status: Terminated
Initiated: 2011-06-29
Posted: 2011-08-11
Terminated: 2014-01-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system
Product code: IZL System, X-Ray, Mobile
Reason for recall: When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240:
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.
Quantity in commerce: 18
Distribution: Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.
Product codes and lots: Model number 10094012; serial numbers 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432. Model number 7008530; serial numbers 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120.

Product code IZL

K040675Class IIAxiom Artis USiemens Medical Systems, Inc. / cleared 2004-06-10

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)