Recall – Video based 3D surface imaging system

Company: Vision RT Ltd
Date of Enforcement Report 10/10/2018
Class II:

PRODUCT
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only

Recall Number: Z-0065-2019

REASON
RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB

RECALLING FIRM/MANUFACTURER
Vision RT Ltd London, United Kingdom on 8/24/2018

Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
690 systems

DISTRIBUTION
Nationally and Internationally.

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ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.