FDA-Device2013-07-31Class II

Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

Siemens Medical Solutions USA, Inc
Hazard

Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squee

Sold states
Nationwide Distribution.
Affected count
401
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1795-2013

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