Device product
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
Z-0464-2015
Product summary
- Firm
- Vision Rt Inc
- Event
- Event 69515
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 (Six Units distribited in the US and One in OUS.)
- Official record key
device-enforcement:Z-0464-2015
Official wording
Reason: Potential failure of AlignRT to assert interlock.
Code information: Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.
Distribution pattern: Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
Derived failure modes
-
Unknown
Potential failure of AlignRT to assert interlock.