Z-1303-2018 Class II Terminated
FDA device recall Z-1303-2018 was initiated by Siemens Medical Solutions USA, Inc on Jan 8, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 22, 2020). Affected quantity: 236 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 11, 2018
- Initiation Date
- Jan 8, 2018
- Termination Date
- Apr 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236 units
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Distribution Pattern
Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Code Information
Model Number 10496180
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1303-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026