Z-0001-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2017
- Initiation Date
- August 30, 2017
- Termination Date
- January 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 devices
Product Description
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 Pattern
Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
Code Information
Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.