Recall Z-1778-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1778-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-27

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-03-27, terminated 2020-06-15. It names one FDA 510(k) clearance: K123375. Product: Syngo.Via VB20A model 1049610. Reason: Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-03-27
Terminated: 2020-06-15
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 VB20A model 1049610

Reason for recall

Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.

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