FDA recall Z-0001-2018

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-30

Report date

2017-10-11

Termination date

2018-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oberkochen, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2018