Vision Rt Inc: Medical Device Recall in 2014 - (Recall #: Z-0464-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 15, 2014

Date Posted: December 3, 2014

Recall Number: Z-0464-2015

Event ID: 69515

Reason for Recall:

Potential failure of AlignRT to assert interlock.

Status: Terminated

Product Quantity: 7 (Six Units distribited in the US and One in OUS.)

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.

Voluntary or Mandated:

Voluntary: Firm initiated