Z-0464-2015 Class II Terminated
FDA device recall Z-0464-2015 was initiated by Vision Rt Inc on October 15, 2014 and is designated Class II. Reason for recall: Potential failure of AlignRT to assert interlock. The recall status is terminated (terminated May 10, 2016). Affected quantity: 7 (Six Units distribited in the US and One in OUS.).
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- October 15, 2014
- Termination Date
- May 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 (Six Units distribited in the US and One in OUS.)
Product Description
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.
Reason for Recall
Potential failure of AlignRT to assert interlock.
Distribution Pattern
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
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.