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Cios Spin

by Siemens Medical Solutions USA, Inc. 2 variants

510(k) K181550

Cios Spin is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K181550 on 30 Oct 2018, active as of 22 Oct 2026. 4 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181550 Date30 Oct 2018ClearedStatusActive

Official records

Recalls

4 recalls · FDA

    • Terminated Z-2888-2020 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.

    • Terminated Z-1959-2020 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-2128-2020 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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K181550
  2. Recall initiated FDA recalls Z-2128-2020
  3. Recall initiated FDA recalls Z-1959-2020
  4. Recall initiated FDA recalls Z-2848-2020
  5. Recall initiated FDA recalls Z-2888-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWB
Device class
Class II
Regulation
21 CFR Part 892.1650
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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