—#148056

Product

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

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092519, K123375
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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.

Timeline

Recall initiated: 2016-06-23
Terminated: 2020-02-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148056. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.