FDA-Device2017-10-11Class IIMISBRANDING
Carl Zeiss INTRABEAM PRS 500 radiation therapy device recalled for incorrect calibration certificate
Nationwide distribution
Check Carl Zeiss INTRABEAM calibration certificate
Nine Carl Zeiss INTRABEAM PRS 500 radiation therapy devices were distributed with incorrect calibration values printed on their calibration certificates. This could affect the accuracy of radiation therapy treatments if the wrong calibration data is used.
- If your facility uses an INTRABEAM device, check the serial numbers against the affected list
- Verify the calibration certificate matches the actual device calibration before treatment
- Contact Carl Zeiss Meditec AG or your equipment representative for corrected documentation
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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