Siemens recalls Artis Icono biplane and floor models with specific serial numbers due to rare risk of X-ray system shutdown if error detection fails. Affected units may require repair.
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Siemens is recalling Artis Icono biplane and floor X-ray systems with specific serial numbers because a hardware issue could cause the system to shut down unexpectedly if error detection fails. This might prevent X-ray imaging during procedures.
The error detection mechanism in the X-ray tubes might fail in rare cases, causing the system to shut down unexpectedly. This could prevent X-ray imaging during medical procedures if the error isn't detected and corrected.
Medical facilities using Artis Icono biplane or floor models with the listed serial numbers are most at risk. Patients undergoing X-ray procedures with these systems could face interrupted imaging.
Check for Artis Icono biplane model 11327600 or floor model 11327700 with serial numbers listed in the recall notice. The recall includes specific serial numbers provided in the notice.
Verify your device's serial numbers against the list provided in the recall notice to confirm if it's affected.
Reach out to Siemens Medical Solutions USA, Inc. for guidance on next steps if your device is listed.
Siemens has identified a potential hardware issue with specific X-ray tubes that could cause the system to shut down unexpectedly if error detection fails.
Check your Artis Icono biplane or floor model's serial numbers against the list provided in the recall notice.
No, but if your device is affected, contact Siemens for guidance on next steps as the system may need repair.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1647-2022 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1647-2022 from Siemens. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
