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Brainlab AG recalls RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Lina
Recalled January 20, 2016 · FDA recall Z-0647-2016 · Brainlab AG
Hazard
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0. · FDA Class II
Units
20 systems
Sold at
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Mexico, Portugal, South Korea, Spain, Switzerland, Turkey and the United Kingdom.
Description
Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0.
Product
RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms
Manufacturer(s)
Brainlab AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →