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Vision Rt Inc recalls AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radio
Recalled December 3, 2014 · FDA recall Z-0464-2015 · Vision Rt
Hazard
Potential failure of AlignRT to assert interlock. · FDA Class II
Units
7 (Six Units distribited in the US and One in OUS.)
Sold at
Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
Description
Potential failure of AlignRT to assert interlock.
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.
Manufacturer(s)
Vision Rt Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →