Device product
Synergy XVI Intended for radiation therapy treatment.
Z-1724-2014
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 68255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380 US
- Official record key
device-enforcement:Z-1724-2014
Official wording
Reason: XVI can incorrectly calculate the target position of the treatment table.
Code information: XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1
Distribution pattern: Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
Derived failure modes
-
Unknown
XVI can incorrectly calculate the target position of the treatment table.