Z-2302-2020Class II

Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q...

Name: Z-2302-2020 Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q...
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-04-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-04-30 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc began a recall of Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model... on 2020-04-30. FDA classified it as Class II and gives the reason as "Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned...". 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-2302-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-06-09
Terminated: 2020-09-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 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: Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens Healthineers issued Urgent Medical Device Correction via AX036/19/S, dated 4/30/20, letter states reason for recall, health risk, and action to take: Siemens will exchange the affected power distributor of the Multi Display Manager. We advise you not to move the Multi Display Manager Container or to open the power distributor before the corrective action can be completed. A service organization will contact you to schedule an appointment to perform the correction via Update Instruction AX035/19/S. Please feel free to contact service organization at 1-800-888-7436 for an earlier appointment. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented; Acknowledge Receipt of this Safety Advisory Notice, By signing this document, you are acknowledging that you have read and understand the content therein.
Quantity in commerce: 15 US
Distribution: US Nationwide distribution.
Product codes and lots: Serial Numbers: Serial 125253 103340 121526 121521 103335 109621 138311 148418 147237 109620 136555 121520 121525 121518 125254

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2302-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-17	2020-06-09

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)