Cios Alpha

• • Terminated Z-2887-2020 FDA Class II ·initiated 30 Jul 2020

  Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

• • 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.

• 2 recalls, same reason

  • Terminated Z-1958-2020 FDA Class II ·initiated 20 Apr 2020
  • Terminated Z-1957-2020 FDA Class II ·initiated 20 Apr 2020

  Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

• • Terminated Z-2127-2020 FDA Class II ·initiated 17 Apr 2020

  The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

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

  DAP chamber may be missing an insulating foil

• • Terminated Z-1295-2019 FDA Class II ·initiated 22 Mar 2019

  Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists

510(k) Number

K181560 ↗

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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