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INTRABEAM
Carl Zeiss Meditec AG · Model 700 · UDI-DI 04049539064080
JAD
Prescription
1
510(k) clearances
78
Adverse events (1 deaths)
12
Recalls
20
Facilities
Description
The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be placed in the environment of the operating theatre, but outside of the sterile medical environment. It is intended to deliver, monitor, and report a radiation therapy treatment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Carl Zeiss Meditec AG | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| 2023-02-10 | Sensus Healthcare, Inc. | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. |
| 2022-04-27 | Xstrahl Limited | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| 2021-08-27 | Xstrahl Limited | Base plate may detach from the main body of the treatment applicator. |
| 2021-04-26 | Xstrahl Limited | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages |
| 2017-08-30 | Carl Zeiss Meditec AG | The device had an incorrect printed calibration value on the calibration certificate. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2011-07-01 | Carl Zeiss Meditec, Inc. | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.