Reported Oct 11, 2017 · Terminated
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena,…
Carl Zeiss Meditec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec AG · Rudolf-Eber-Str. 11 · Oberkochen, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Intrabeam ser. #6402501246, Ion chamber ser. #SN001254 2 Intrabeam ser. #6402501241, Ion chamber ser. #SN001745 3 Intrabeam ser. #6402100932, Ion chamber ser. #SN001994 4 Intrabeam ser. #6402100958, Ion chamber ser. #SN002096 5 Intrabeam ser. #6402101042, Ion chamber ser. #SN002265 6 Intrabeam ser. #6402101029, Ion chamber ser. #SN002270 7 Intrabeam ser. #6402101034, Ion chamber ser. #SN002302 8 Intrabeam ser. #6402101105, Ion chamber ser. #SN002651 9 and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684. - Amount recalled
- 9 devices
Where it was sold
Why it was recalled
The device had an incorrect printed calibration value on the calibration certificate.
This product could cause temporary or reversible health problems — stop using it.
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