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…

Recall date

August 30, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0001-2018

FDA classification

Class II

Brand / firm

Carl Zeiss Meditec AG

Sold / distributed

Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.

Why it was recalled

The device had an incorrect printed calibration value on the calibration certificate.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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