Siemens recalls ARTIS pheno angiography systems with specific table models due to potential 5-10mm C-arm positioning error during procedures, risking patient or staff injury.
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
Siemens is recalling certain ARTIS pheno angiography systems that may cause the C-arm to move inaccurately by 5-10mm during procedures, potentially crushing patients or staff. This could also lead to inaccurate imaging and vessel perforations.
If the C-arm is positioned outside the working range during a procedure and the 'Adjust C-arm to Ref' function is activated, the C-arm may move 5-10mm inaccurately. This can cause unintended movement that crushes patients, staff, or equipment, and leads to inaccurate imaging that might perforate blood vessels.
Healthcare facilities using the recalled ARTIS pheno systems with Siemens Healthineers or Trumpf/MAQUET tables are affected. Medical staff and patients using these systems during procedures are at risk.
Check for the model number 10849000 on the system, or serial numbers starting with 164000-164400. The system includes either a Siemens Healthineers table or a Trumpf/MAQUET table (OEM).
Verify the system model number is 10849000 and the serial number starts with 164000-164400.
Reach out to Siemens Medical Solutions USA, Inc. for further assistance with the recall.
The recalled systems have model number 10849000 with serial numbers starting with 164000-164400.
Yes, the issue could cause crushing injuries to patients or staff, or vessel perforations during procedures.
Check if your system matches the model and serial numbers listed, then contact Siemens Medical Solutions USA, Inc. for further instructions.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1498-2023 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1498-2023 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.
