Siemens recalls specific ARTIS Pheno interventional fluoroscopy systems due to potential C-arm movement failures affecting imaging procedures. Affected units have serial numbers starting with 164011.
If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer
Siemens is recalling certain ARTIS Pheno interventional fluoroscopy systems because a drivetrain fault could cause the C-arm to move unexpectedly, making it impossible to reach the target area during procedures. This could lead to failed imaging or the need for a technician to reset the system, which might delay critical medical treatments.
If the C-arm's drivetrain develops a fault, it may leave its intended travel path, causing movements to be impacted or impossible. This means the medical team might not be able to reach the target area during procedures, potentially leading to failed imaging or requiring a technician to manually reset the system.
Healthcare facilities using the recalled ARTIS Pheno systems, particularly those performing interventional procedures on patients. Medical staff and patients at facilities with the affected serial numbers are most at risk.
Check if your system has a serial number starting with 164011 through 164293. The ARTIS Pheno interventional fluoroscopy system is used for procedures like angiography and interventional imaging in hospitals.
Verify if your system has a serial number starting with 164011 through 164293. The affected models are used for interventional procedures in hospitals.
Reach out to Siemens Medical Solutions USA, Inc. for guidance on system status and next steps. They will assist with resetting the system if needed.
The C-arm's drivetrain may develop a fault that causes it to leave its intended travel path, making movements impossible and preventing the target area from being reached during procedures.
Check if your system has a serial number starting with 164011 through 164293. The ARTIS Pheno interventional fluoroscopy system is used for procedures like angiography and interventional imaging in hospitals.
Contact Siemens Medical Solutions USA, Inc. for guidance on system status and next steps. They will assist with resetting the system if needed.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-2108-2020 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-2108-2020 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.
