FDA-Device2017-10-11Class II
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Carl Zeiss Meditec AG
Hazard
The device had an incorrect printed calibration value on the calibration certificate.
Sold states
Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Affected count
9 devices
Manufactured in
Rudolf-Eber-Str. 11, N/A, Oberkochen, N/A, Germany
Products
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2018Don't want to check this manually?
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