Device product
ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Z-0472-2023
Product summary
- Event
- Event 91182
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units US
- Official record key
device-enforcement:Z-0472-2023
Official wording
Reason: When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter
Code information: UDI: N/A S/N: 10736, 10737, 10822, 10850, 10886,10843, 10865,10025 Software version 4.3.1 MR3
Distribution pattern: US Nationwide distribution in the states of CA, IA, LA, NE, NV, OH, SC.
Derived failure modes
-
Unknown
When selecting the site fraction group for treatment, the User may select the wrong site for treatment, and potentially deliver the dose to wrong isocenter