Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 4/11/2018
Class lI:
PRODUCT
Syngo.via. Medical Device Software. Picture archiving and communications system
Recall Number Z-1303-2018
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.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/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 1/8/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
236 units
DISTRIBUTION
Device is software only. No products are distributed to wholesale dealers, distributers or retailers
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