FDAFDA · Food and drugs·Recall number Z-0001-2018
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
Published October 11, 2017 · Recall initiated: August 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The device had an incorrect printed calibration value on the calibration certificate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec AG
- Distributor
- Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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