Recall Z-1303-2018— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1303-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-08

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-01-08, terminated 2020-04-22. It names one FDA 510(k) clearance: K123375. Product: Syngo.via. Medical Device Software. Picture archiving and communications system.. Reason: A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-01-08
Terminated: 2020-04-22
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. Medical Device Software. Picture archiving and communications system.

Reason for recall

A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system.

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