Company:Vision Rt Inc.
Date of Enforcement Report 12/3/2014
Class lI:
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.
Recall Number Z-0464-2015
REASON
Potential failure of AlignRT to assert interlock.
RECALLING FIRM/MANUFACTURER
Vision Rt Inc., Columbia MD 10/15/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7 (Six Units distribited in the US and One in OUS.
DISTRIBUTION
Nationwide and Ireland
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