Axiom Artis X-Ray System using software version VB11D or VB20B
FDA Recall Z-0796-05 · Posted 2005-05-03
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2005-04-11
Date Terminated2006-08-23
Product Quantity295 units
Reason for Recall
Live display in exam room may sporadically stop working although the display in the control room remains fully operational
Firm Action
The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.
Root Cause
Other
Distribution Pattern
The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
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.