Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Carl Zeiss INTRABEAM PRS 500 Recalled by Carl Zeiss Meditec AG Due to The device had an incorrect printed calibration value...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Carl Zeiss Meditec AG directly.
Affected Products
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
Quantity: 9 devices
Why Was This Recalled?
The device had an incorrect printed calibration value on the calibration certificate.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carl Zeiss Meditec AG
Carl Zeiss Meditec AG has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report