Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report:5/3/2006
Class:lI
PRODUCT
AXIOM Artis X-ray systems running software versions VB11K and VB22-G, AXIOM Artis FC model number 5904433, AXIOM Artis BC model number 5904649, AXIOM Artis MP model number 5904466, AXIOM Artis FA model number 5904441, AXIOM Artis BA model number 5904656, AXIOM Artis TC model number 7728350, AXIOM Artis TA model number 7007755, AXIOM Artis dFC model number 7412807, AXIOM Artis dFC-MN model number 7727717, AXIOM Artis dBC model number 7728392, AXIOM Artis dTC model number 7413078, AXIOM Artis dFA model number 7555373, AXIOM Artis dBA model number 7555357, AXIOM Artis dTA model number 7008605, AXIOM Artis dMP model number 7555365.
Recall # Z-0809-06;
REASON
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.
CODE
Software versions VB11K and VB22-G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc, Malvern, PA, by letter on March 10, 2006.
Manufacturer: Siemens Medical Solutions, Forchheim, Germany, firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
287 units
DISTRIBUTION
Nationwide
