Siemens Medical Solutions USA, Inc Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option

Recommended Action

Per FDA guidance

Siemens issued A Customer Safety Advisory Notice dated 10/12/21 to affected customers via AX047/21/S. Additionally, a software update will be initiated for all affected users via Update Instruction AX046/21/S. Letter states reason for recall, health risk and action to take: To avoid inaccurate measurement values, repeat the distance measurements after changing the Auto TOD Calibration or Distance Calibration of the scene. Additionally, before closing the image after performing the calibration, create a screenshot/secondary capture image for post review. The Operator Manual of the affected systems will be updated according to the information mentioned above. This is regarded as an interim solution until the next software update is available. The Operator Manual update will draw attention to the issue. We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 4) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable. Siemens will correct the software error via Update Instruction AX046/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.