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Recall Observatory FDA recall evidence

Device product

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815

Z-0200-2022

September 24, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 88820
Status
Ongoing
Classification
Class II
Quantity
43 US
Official record key
device-enforcement:Z-0200-2022

Official wording

Reason: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient

Code information: Artis zeego systems with Artis patient table and AppSW VD20C/VD20N

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software error, the software can produce an incorrect