Recall Z-0001-2018 ยท JAD System, Therapeutic, X-Ray
Carl Zeiss Meditec AG
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
| Date | Aug 30, 2017 |
| Status | Terminated |
| Reason | The device had an incorrect printed calibration value on the calibration certificate. |
| Root cause | Process control |
| Action | 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 conf |
| Quantity | 9 devices |
| Distribution | Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051055 | INTRABEAM SYSTEM Carl Zeiss Surgical GmbH, May 23, 2005 |
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS Carl Zeiss Surgical GmbH, Nov 24, 2009 |
| K110590 | INTRABEAM NEEDLE APPLICATOR Carl Zeiss Surgical GmbH, Apr 13, 2012 |
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS Carl Zeiss Meditec, Inc., Dec 27, 2012 |
| K130549 | INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR Carl Zeiss Meditec, Inc., Jun 26, 2013 |