Multix Fusion

510(k) K121513

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK121513	Date10 Aug 2012Cleared	StatusActive

4 recalls · FDA

- Terminated Z-0297-2019 FDA Class II initiated 3 Aug 2018
Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning
2 recalls, same reason
- Terminated Z-0013-2017 FDA Class II initiated 1 Aug 2016
- Terminated Z-0014-2017 FDA Class II initiated 1 Aug 2016
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
- Terminated Z-1505-2014 FDA Class II initiated 13 Feb 2014
It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b

1 jurisdiction

United States — FDA 510(k) Active

510(k)