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Terminated

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

FDA Recall Z-2245-2016 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-06-23
Date Terminated2020-02-20
Product Quantity50 units

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123375SYNGO.VIASiemens AG · 2012-11-20K092519SYNGO.XSiemens AG Medical Solutions · 2009-08-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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