CLASS II Device recall · Reported 27 Jul 2016 · FDA Enforcement Report

Syngo.via, picture archiving and communications system recalled

Siemens Medical Solutions USA is recalling Syngo.via, picture archiving and communications system, distributed nationwide in the US. The recall was initiated on 23 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes310289,130542,130322,310149,130325,221063,310168,101762,221048,221096,220783,310195,130451,400031,130292,310114,220846,130269,130163,130402,130826,221051,102336,310282,220888,10007,221052,221049,130518,221002,221091,220915,130520,130472,100469,310249,130122,100013,130378,310188,102453,310079,310080,130240,130382,220985,310171,220879,220995, and 310268.

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2245-2016
FDA event ID: 74620
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 23 Jun 2016
FDA classified: 19 Jul 2016
Reported: 27 Jul 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

23 Jun 2016	Recall initiated by company
19 Jul 2016	Classified by FDA	+26 days
27 Jul 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.

Where it was distributed

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.

Nationwide Arkansas California Colorado Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Dakota Nebraska New Jersey

Questions about this recall

Why was it recalled?

Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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