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Carl Zeiss Meditec AG recalls Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germ
Recalled October 11, 2017 · FDA recall Z-0001-2018 · Carl Zeiss Meditec AG
Hazard
The device had an incorrect printed calibration value on the calibration certificate. · FDA Class II
Units
9 devices
Sold at
Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Description
The device had an incorrect printed calibration value on the calibration certificate.
Product
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
Manufacturer(s)
Carl Zeiss Meditec AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →