SIEMENS AXIOM Artis - AUTOMAP FUNCTION
FDA Recall Z-1108-04 · Posted 2004-07-20
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2004-06-02
Date Terminated2004-10-21
Product Quantity127 units
Reason for Recall
Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash.
Firm Action
The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.
Root Cause
Other
Distribution Pattern
The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, 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.