Device product
Oncentra Brachy radiation therapy planning system software.
Z-0719-2023
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 91224
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 336 systems
- Official record key
device-enforcement:Z-0719-2023
Official wording
Reason: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Code information: Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.
Distribution pattern: Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Derived failure modes
-
Unknown
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling