Recall Z-0808-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0808-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-31

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2017-08-31, terminated 2018-10-01. It names one FDA 510(k) clearance: K123375. Product: Syngo.via systems with SW VB20A. Reason: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Terminated: 2018-10-01
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K123375 — SYNGO.VIASiemens AG·cleared 2012-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Syngo.via systems with SW VB20A

Reason for recall

A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.