Z-2307-2018Class II

Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures

Name: Z-2307-2018 Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-05-01
License: https://open.fda.gov/license/

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

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures on 2018-05-01. FDA classified it as Class II and gives the reason as "After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2307-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Posted: 2018-06-27
Terminated: 2019-05-16
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Root cause tag: design
FDA root cause: Device Design
Action: On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing emergency procedures until the update has been completed. The firm's service organization will contact customers to arrange a date to correct the error by updating the firmware of the affected devices. Users were asked to promptly notify and instruct accordingly all staff within their organizations who need to be aware of the issue.
Quantity in commerce: 1
Distribution: Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: 105007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2307-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2303-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2304-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2305-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2306-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2307-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2308-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2309-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2310-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2311-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2312-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2313-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27
Z-2314-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-27

Product code OWB

K123529Class IIArtis Q and Q.zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2013-02-26

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)