Company: Elekta, Inc.
Date of Enforcement Report: 7/24/2019
Class II
PRODUCT
Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Recall Number: Z-1980-2019
REASON
The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.
RECALLING FIRM/MANUFACTURER
Elekta, Inc. on 7/24/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
US Nationwide and International