Axiom Aristos Fx (Multi Purpose Radiography System)

• • Terminated Z-1764-2020 FDA Class II ·initiated 6 Apr 2020

  It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall dose is estimated at 0.01mSv or less than 500 mGy in total.

• • Terminated Z-1583-2015 FDA Class II ·initiated 14 Apr 2015

  If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.

• • Terminated Z-1959-2011 FDA Unclassified (pre-2012) ·initiated 17 Feb 2011

  During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha rotation, the detector may descend unexpectedly during movement or in vertical or table mode. If this occurs in vertical modes, the possibility exists that the detect

• • Terminated Z-0163-2009 FDA Unclassified (pre-2012) ·initiated 25 Aug 2008

  Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.

• 3 recalls, same reason

  • Terminated Z-0990-05 FDA Unclassified (pre-2012) ·initiated 10 Jun 2005
  • Terminated Z-0989-05 FDA Unclassified (pre-2012) ·initiated 10 Jun 2005
  • Terminated Z-0988-05 FDA Unclassified (pre-2012) ·initiated 10 Jun 2005

  potential issue (system may lock up) when repeating patient registrations

• • Terminated Z-0984-03 FDA Unclassified (pre-2012) ·initiated 19 Apr 2003

  software malfunction. May indicate that the image is flipped when it is not.

510(k) Number

K013826 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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