Z-0508-2018Class II

AArtis Q/ Q.Zen biplane Artis zee biplane

Name: Z-0508-2018 AArtis Q/ Q.Zen biplane Artis zee biplane
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-08-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-08-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging... on 2017-08-24. FDA classified it as Class II and gives the reason as "Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality...". 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-0508-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-24
Posted: 2018-02-03
Terminated: 2018-08-29
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AArtis Q/ Q.Zen biplane Artis zee biplane 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: Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Siemens sent an Urgent: Medical Device Correction letter dated August 24, 2017 to all affected customers. The letter identified the affected product, problem and actions to be taken. A local management or dispatch will schedule for an inspection to correct the issue. For questions please call 1-800-888-7436
Quantity in commerce: 265 units
Distribution: US Nationwide Distribution
Product codes and lots: 10094141 10848282 10848355

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0508-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0508-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-02

Product code OWB

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)