Recall StatusTerminated
Date Initiated2021-06-30
Date Terminated2023-02-10
Product Quantity70 US (172 WW)
Reason for Recall
Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart,
and result in delay of clinical treatment
Firm Action
Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to affected customers via AX045/21/S dated 6/30/21. Letter states reason for recall, health risk and
action to take:
If the BYPASS/ BYPASS FLUORO message does not disappear after approximately four minutes, an additional restart of the Artis system is necessary.
Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed.
Siemens will provide a software update for all affected systems via Update Instruction AX044/21/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.
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 distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA,
MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.
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.