Axiom Aristos TX. Model number 58 94 873 Radiology system
FDA Recall Z-0988-05 · Posted 2005-07-13
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeKPR
Date Initiated2005-06-10
Date Terminated2006-08-30
Product Quantity72 units
Reason for Recall
potential issue (system may lock up) when repeating patient registrations
Firm Action
The recalling firm issed a Customer Advisory Letter via certified mail to their cutomers informing them of the problem and information for the workaround to prevent problems for occurring until the software is upgraded.
Root Cause
Other
Distribution Pattern
Nationwide. The products were shipped to hospitals in AZ, CA, CO, FL, GA, IL, IN, KS, KY, ME, MI, MO, NC, NE, NJ, NY, OK, PA, TN, TX, UT, VA, WA, and 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.