Recalls / —

—#40246

Product

Axiom Aristos FX. Model number 74 14 803

FDA product code

KPR — System, X-Ray, Stationary

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K013826

Affected lot / code info

Serial numbers 1001 through 1003, 1005 through 1047, and 1049 through 1247.

Why it was recalled

potential issue (system may lock up) when repeating patient registrations

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

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.

Timeline

Recall initiated

2005-06-10

Posted by FDA

2005-07-13

Terminated

2006-08-30

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #40246. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.