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Siemens Medical Solutions USA, Inc recalls ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s
Recalled May 10, 2023 · FDA recall Z-1498-2023 · Siemens Medical Solutions USA
Description
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.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →