PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 31, 2013 Initiated: June 5, 2013 #Z-1795-2013

Product Description

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

Reason for Recall

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

Details

Units Affected
401
Distribution
Nationwide Distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 401.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2013. Severity: Moderate. Recall number: Z-1795-2013.