Z-2245-2016Class II

Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing...

Name: Z-2245-2016 Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-06-23
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-06-23 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of... on 2016-06-23. FDA classified it as Class II and gives the reason as "Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors". 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-2245-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2016-07-20
Terminated: 2020-02-20
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.
Root cause tag: software
FDA root cause: Software design
Action: Siemens released and mailed to customers a notice with software update VB30B instructions via update instruction SY018/16/P for customers to follow until the update can be made. The letter also described the software issues involved; and asked customers to include the letter in the operator's manual until the update is performed. Customers are to ensure that all necessary personnel are aware of the situation.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution -- AR, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TX, and UT.
Product codes and lots: 310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2245-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2245-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-19

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)