Cios Alpha

• • Terminated Z-2848-2020 FDA Class II ·initiated 14 Jul 2020

  Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D80 (below revision 04 installed) of the generator which is part of the main unit (c-arm) and cause permanent loss of imaging functionality.

• • Terminated Z-0782-2020 FDA Class II ·initiated 25 Nov 2019

  During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

• • Terminated Z-1953-2019 FDA Class II ·initiated 20 Jun 2019

  DAP chamber may be missing an insulating foil

• • Terminated Z-1298-2019 FDA Class II ·initiated 18 Mar 2019

  Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.

• • Terminated Z-1278-2016 FDA Class II ·initiated 19 Feb 2016

  Software issues on Cios Alpha mobile C-Arm system

• • Terminated Z-1281-2016 FDA Class II ·initiated 16 Feb 2016

  Siemens found a defective part in their production line which could increase risk of an electrical shock for service personnel when working inside the device during system maintenance. The risk of an electrical shock is only present when a service technician ignores several steps listed in the service manual as precautionary actions during device maintenance.

• • Terminated Z-0118-2016 FDA Class II ·initiated 17 Aug 2015

  patient procedure interruption due to a potential system failure

• • Terminated Z-1958-2015 FDA Class II ·initiated 5 May 2015

  under certain circumstances the Cios Alpha system may freeze during a procedure.

510(k) Number

K132094 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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