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
Product summary
- 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
Software error, the software can produce an incorrect