Z-0319-2016Class II

Syngo Imaging VB36D_HF02. Radiological image processing system

Name: Z-0319-2016 Syngo Imaging VB36D_HF02. Radiological image processing system
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-10-28
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-10-28 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo Imaging VB36D_HF02. Radiological image processing system on 2015-10-28. FDA classified it as Class II and gives the reason as "To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D". 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-0319-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-28
Posted: 2015-11-20
Terminated: 2016-10-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo Imaging VB36D_HF02. Radiological image processing system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D.
Root cause tag: software
FDA root cause: Software change control
Action: Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call: (610) 219-6300.
Quantity in commerce: 3
Distribution: US Distribution to the states of : NC, NE and OH.
Product codes and lots: model# 10014063 and 10014064

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0319-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0319-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-20

Product code LLZ

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)