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Recall Observatory FDA recall evidence

Device product

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

Z-2245-2016

June 23, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 74620
Status
Terminated
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-2245-2016

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Incorrect values for the volume calculation. Software