Z-0200-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 10, 2021
- Initiation Date
- September 24, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43 US
Product Description
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
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
Artis zeego systems with Artis patient table and AppSW VD20C/VD20N