AXIOM Artis X-ray systems running software versions VB11K and VB22G
FDA device recall Z-0809-06 · posted 2006-04-26 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 287
- Distribution
- 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 a
- Date initiated
- 2006-03-10
- Date posted
- 2006-04-26
- Date terminated
- 2006-08-30
- Location
- Malvern, PA
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