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Terminated

Axiom Aristos FX. Model number 74 14 803

FDA Recall Z-0990-05 · Posted 2005-07-13

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.

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