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
Reported: October 11, 2017 Initiated: August 30, 2017 #Z-0001-2018
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.
Details
- Recalling Firm
- Carl Zeiss Meditec AG
- Units Affected
- 9 devices
- Distribution
- Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.
- Location
- Oberkochen, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Carl Zeiss Meditec AG. Units affected: 9 devices.
Why was this product recalled? ▼
The device had an incorrect printed calibration value on the calibration certificate.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2017. Severity: Moderate. Recall number: Z-0001-2018.
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