Z-3005-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 30, 2020
- Initiation Date
- August 19, 2020
- Termination Date
- April 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 systems US
Product Description
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Reason for Recall
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
Distribution Pattern
US Nationwide distribution.
Code Information
Serial Numbers: 100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 100811 100812 100813 100814 101724 102013 102031 102108 102305 102369 130125 130140 130331 130335 130628 130751 130848 130874 131012 131169 131247 131284 131325 131336 131360 131503 131578 131589 131801 131966 132011 132061 132102 132108 132136 132231 132595 132729 222224 222411 222417 222475 222491 222539 222563 222601 222638 222686 222946 223004 223084 451001