Artis icono floor in combination with a Siemens… recallZ-0986-2022 · Siemens Medical Solutions USA, Inc · initiated Feb 25, 2022

Why it was recalled

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

FDA root cause category: Software Design Change

What the company is doing

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

Recall details

Recall number

Z-0986-2022

Status

Open, Classified

Initiated by the company

Feb 25, 2022

Recalling firm

Siemens Medical Solutions USA, Inc

Quantity

35 units

Product code

OWB

FDA submissions

K193326

Distribution

US Nationwide distribution.

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• ARTIS icono floor 11327700

  Siemens Healthcare GmbH · System, x-ray, tomography, computed
  15 recalls24 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 89870).

• Z-0985-2022 · Open, Classified
  Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedure…
• Z-0987-2022 · Open, Classified
  Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model…