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Terminated

AXIOM Artis X-ray systems running software versions VB11K and VB22G

FDA Recall Z-0809-06 · Posted 2006-04-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2006-03-10
Date Terminated2006-08-30
Product Quantity287

Reason for Recall

The recalling firm became aware of a potential problem when imaging patients on their stomach on the AXIOM Artis X-ray Systems running software versions VB11K and VB22G. In some instances, the orientation labels could be incorrect.

Firm Action

The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX011/06/S and AX013/06/S, on 3/10/2006. This informs customers of the potential problem and provides a recommendation to avoid this issue.

Root Cause

Other

Distribution Pattern

Nationwide. The product was shipped to medical facilities in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL,IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI and WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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