Carl Zeiss Meditec AG: Medical Device Recall in 2017 - (Recall #: Z-0001-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 30, 2017

Date Posted: October 11, 2017

Recall Number: Z-0001-2018

Event ID: 78082

Reason for Recall:

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

Status: Terminated

Product Quantity: 9 devices

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated