Device product
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Z-1795-2013
Product summary
- Event
- Event 65604
- Status
- Terminated
- Classification
- Class II
- Quantity
- 401
- Official record key
device-enforcement:Z-1795-2013
Official wording
Reason: 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
Code information: Model Number 5895003 with serial numbers 1052 through 2500.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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