Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
FDA device recall Z-2649-2026 · posted 2026-07-01 · Open, Classified
Recall details
- Recalling firm
- Carl Zeiss Meditec AG
- Reason for recall
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Action taken
- 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 replacement of your applicator and collect the recalled applicator from you. 4. This recall letter should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- JAD
- Quantity affected
- 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.
- Date initiated
- 2026-06-01
- Date posted
- 2026-07-01
- Location
- Oberkochen, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS (K121653) | Carl Zeiss Meditec, Inc. | 2012-12-27 |