Home / Recalls / Medical Devices
Siemens Medical Solutions USA, Inc recalls Syngo.via. Medical Device Software. Picture archiving and communications system.
Recalled April 11, 2018 · FDA recall Z-1303-2018 · Siemens Medical Solutions USA
Hazard
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system. · FDA Class II
Units
236 units
Sold at
Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Description
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Product
Syngo.via. Medical Device Software. Picture archiving and communications system.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →