Z-0469-2021Class II

Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material...

Name: Z-0469-2021 Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-10-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-10-21 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 -... on 2020-10-21. FDA classified it as Class II and gives the reason as "Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an...". 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-0469-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-21
Posted: 2020-11-18
Terminated: 2021-05-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: 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: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On October 21, 2020, the firm notified customers via Urgent Medical Device Correction letter. The letter informed customers of the hardware error, and that customers could continue to use their system but needed to follow their standard emergency procedures they had in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all affected users via Update Instruction AX018/20/S. The Siemens Service organization will exchange the affected printed circuit boards of the generator. This modification will bring the voltage back to the center of the tolerance range. Siemens' service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Quantity in commerce: 26 distributed worldwide (4 in US)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.
Product codes and lots: Serial numbers 109762 111158 124344 111161

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0469-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-25	2020-11-18

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

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)