Recall Z-2649-2026 ยท JAD System, Therapeutic, X-Ray
Carl Zeiss Meditec AG
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
| Date | Jul 1, 2026 (initiated Jun 1, 2026) |
| Status | Open, Classified |
| Reason | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| Root cause | Employee error |
| Action | On June 12, 2026, Carl Zeiss Meditech issued a Urgent Medical Device Recall to affected consignees via FedEx Priority. Carl Zeiss ask consignees to take the following actions: 1. Immediately discontinue use of any affected applicator identified in this notice and segregate/quarantine it to prevent further use. 2. Complete, sign, and return the attached Acknowledgement and Receipt Form to CZMUI in accordance with the instructions provided on the form. 3. Once the Acknowledgement and Receipt Form has been received by CZMUI, then a member of our service team will contact you to schedule the repl |
| Quantity | 13 units |
| Distribution | Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121653 | INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS Carl Zeiss Meditec, Inc., Dec 27, 2012 |