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INTRABEAM Spherical Sizer Set

Carl Zeiss Meditec AG · Model 309121-9100-000 · UDI-DI 04049539105509

JAD Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The INTRABEAM Spherical Sizer Set is a sterile disposable product. It is intended to be used in the context of radiation therapy. It shall be used to assess which INTRABEAM SMART Spherical Applicator, or INTRABEAM Spherical Applicator, shall be used for the given radiation therapy treatment using INTRABEAM system, based on the dimensions of the treatment location (intracavitary or intraoperative). It shall be used only with an INTRABEAM device.

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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Data 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.