syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
FDA Recall Z-1339-2022 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusOpen, Classified
Product CodeOWB
Date Initiated2022-02-25
Product Quantity127 units
Reason for Recall
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
Firm Action
Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX007/22/S dated 2/25/22.
Letter states reason for recall, health risk and action to take:
We do not consider it necessary to re-examine any patients previously treated using the syngo application software.
Siemens will correct the software error via Update Instruction AX006/22/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Root Cause
Software design
Distribution Pattern
US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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