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Recall Observatory FDA recall evidence

Device product

Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

Z-2088-2016

May 09, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 74390
Status
Terminated
Classification
Class II
Quantity
74 systems
Official record key
device-enforcement:Z-2088-2016

Official wording

Reason: Software error in previous software versions in which two references for the same image may exist in the database.

Code information: Serial Numbers: 100389, 100198, 100258, 100259, 100538, 100133, 100213, 100214, 100031, 100484, 100362, 100233, 100140, 100141, 100142, 100143, 100144, 100416, 100105, 100106, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100457, 100245, 100447, 100364, 100314, 100298, 100299, 100386, 100139, 100027, 100300, 100197, 100025, 100084 100186, 100189, 100190, 100191, 100192, 100195, 100196, 100033, 100306, 100307, 100232, 100256, 100199, 100188, 100194, 100257, 100425, 100029, 100253, 100132, 100247, 100248, 100434, 100491, 100495, 100221, 100212

Distribution pattern: US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software error