Z-1303-2018Class II

Syngo.via. Medical Device Software. Picture archiving and communications system

Name: Z-1303-2018 Syngo.via. Medical Device Software. Picture archiving and communications system
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-01-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-01-08 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.via. Medical Device Software. Picture archiving and communications system on 2018-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1303-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-08
Posted: 2018-03-20
Terminated: 2020-04-22
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.via. Medical Device Software. Picture archiving and communications system.
Product code: LLZ System, Image Processing, Radiological
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 Outdated information could be sent to the referring physician when creating the formal report in the reporting system.
Root cause tag: software
FDA root cause: Software design
Action: Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice.
Quantity in commerce: 236 units
Distribution: Device is software only. No products are distributed to wholesale dealers, distributers or retailers
Product codes and lots: Model Number 10496180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1303-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1303-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code LLZ

K123375Class IISyngo.viaSiemens AG / cleared 2012-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)