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

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

Zeiss sent a Field Safety Corrective Action letter dated August 30. 2017, to all affected customers via FedEx. Recall letters were issued by the U.S. Agent on behalf of the /recalling firm on 8/30/2017 via FedEx. Customers were given the following instructions: 1. A member of the ZEISS service staff will contact you to coordinate the steps to be taken and to schedule the update of your system. Alternatively, you may update the system yourself by following the attached instructions. In case you update the system yourself, a ZEISS service staff member will still be visiting your site to confirm the updated calibration. 2. Please complete and return the attached response form to acknowledge receipt of this notification. If you have question regarding this field safety corrective action, you can contact your ZEISS customer service at 800-442-4020 or by email at [email protected] with any additional questions. You may also contact me at 925-557-4151 or [email protected]