Z-0986-2022Class II

Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use...

Name: Z-0986-2022 Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-02-25
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-02-25 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and... on 2022-02-25. FDA classified it as Class II and gives the reason as "Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0986-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-04-21
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Root cause tag: software
FDA root cause: Software Design Change
Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to all affected customers via AX005/22/S on 2/28/22. Siemens will provide a software update for all affected systems via Update Instruction AX003/22/S and AX004/22/S. Letter states reason for recall, health risk and action to take: We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 5) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable. Siemens will correct the software error via Update Instruction AX003/22/S and Update Instruction AX004/22/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. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. If you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this notification via Certified Mail, please provide at least two contact names and email addresses of the appropriate personnel within your facility who should receive these notifications electronically. This information will assist in providing you with these important notifications in a more expedient and compliant manner. Please include your Siemens system names, material numbers, serial numbers, and Siemens Functional Location numbers and email this information to: recallsandrefusals.team@siemens-hea
Quantity in commerce: 35 units
Distribution: US Nationwide distribution.
Product codes and lots: S/N: Serial 170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361 170351 170383 170023 170304 170328 170334 170336 170025 170346 170051 170358 170357 170333 170365 170332 170312 170027 170303 170378 170322 170053 170364 UDI: 04056869149325

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0985-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0986-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21
Z-0987-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-27	2022-04-21

Product code OWB

K193326Class IIARTIS IconoSiemens Medical Solutions USA, Inc. / cleared 2020-04-16

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)