Z-0298-2021Class II

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 -

Name: Z-0298-2021 Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-09-21
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-09-21 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part... on 2020-09-21. FDA classified it as Class II and gives the reason as "Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution)". 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-0298-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-21
Posted: 2020-10-27
Terminated: 2021-08-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
Root cause tag: design
FDA root cause: Component design/selection
Action: Siemens issued Urgent Medical Device Correction notification letter dated 9/22/20 via AX053/20/S stating reason for recall, health risk and action to take: Siemens will correct the error with a hardware replacement of the Display Port transceiver via Update Instruction AX052/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our 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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document.
Quantity in commerce: 22 units
Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.
Product codes and lots: Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0298-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0298-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-04	2020-10-27

Product code OWB

K133580Class IIArtis OneSiemens Medical Solutions USA, Inc. / cleared 2014-04-28

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)