Z-1349-2016Class II

A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate...

Name: Z-1349-2016 A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-01-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-01-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical... on 2016-01-18. FDA classified it as Class II and gives the reason as "To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging". 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-1349-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Posted: 2016-04-07
Terminated: 2017-08-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.
Root cause tag: software
FDA root cause: Software design
Action: Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D.
Quantity in commerce: 49 imaging systems
Distribution: US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.
Product codes and lots: Model # 10014063

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1349-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1349-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-13	2016-04-07

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)