The Recall Desk
HighFDA (Devices)·Z-1498-2023·Announced 2023-05-10

Angiography System C-Arm Positioning Malfunction May Cause Patient Injury

Siemens ARTIS pheno angiography systems may misposition the C-arm by 5-10 millimeters when using the reference image positioning function, risking patient and staff crushing injuries. The device may also display inaccurate imaging overlays, potentially causing vessel perforation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a high-risk interventional device with documented potential for patient and staff crushing injuries and vessel perforation. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 141 units of the ARTIS pheno angiography system (Model 10849000), which is distributed nationwide. These systems are used for diagnostic imaging and interventional angiography procedures.

The system has a positioning malfunction. When the 'Adjust C-arm to Ref' function is activated while the C-arm is positioned outside the system's working range, the C-arm reaches its target position with an inaccuracy of 5-10 millimeters. This inaccuracy leads to unintended C-arm movement that can cause crushing injuries to patients, staff members, operators, or equipment. The device displays an 'Endposition reached' message when this occurs.

Additionally, live images acquired during the procedure may not match previously stored reference images. Overlay images used to guide the procedure may be displayed inaccurately on the patient's anatomy. In DSA roadmap procedures, where the overlay should match real anatomy, this misalignment may result in vessel perforation.

Healthcare facilities using this equipment should contact Siemens Medical Solutions USA, Inc. for further instructions on service updates or repairs.

The recalled product

Product
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Angiography / Interventional Imaging
Hazard
  • crushing
  • positioning-inaccuracy
  • image-mismatch
  • vessel-perforation

Distribution

Distributed nationwide across the United States.

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