Recall Z-0464-2015— Vision Rt Inc

Name: FDA recall Z-0464-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-15

Class II · Terminated

Class II FDA medical device recall by Vision Rt Inc, initiated 2014-10-15, terminated 2016-05-10. It names one FDA 510(k) clearance: K123371. 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.. Reason: Potential failure of AlignRT to assert interlock..

Recalling firm: Vision Rt Inc
Classification: Class II
Status: Terminated
Initiated: 2014-10-15
Terminated: 2016-05-10
Firm location: Columbia, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K123371 — ALIGNRT PLUSVision RT Limited·cleared 2013-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.