Bebig Isotopentechnik GmbH
GermanyFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Bebig Isotopentechnik GmbH makes
Bebig Isotopentechnik GmbH manufactures the ISOSEED PD-103, a radioactive seed implant system used for brachytherapy in cancer treatment. This device delivers localized radiation therapy for precise tumor control, particularly in prostate and other solid tumors.
The ISOSEED PD-103 is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Isoseed Pd-103 Ref K993552
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Bebig Isotopentechnik GmbH, initiated on 2023-10-17. By recorded status: 1 ongoing. The reasons filed fall into these groups: software or firmware and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 17 Oct 2023 Z-0517-2024 Class II Ongoing Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
Frequently asked questions
How many devices does Bebig Isotopentechnik GmbH have in the registry?
The registry currently lists 1 device for Bebig Isotopentechnik GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bebig Isotopentechnik GmbH's devices?
Among its 1 most recently registered device, Bebig Isotopentechnik GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Bebig Isotopentechnik GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bebig Isotopentechnik GmbH's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bebig Isotopentechnik GmbH?
FDA recall records list 1 recall initiated by Bebig Isotopentechnik GmbH, the most recent initiated on 17 Oct 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bebig Isotopentechnik GmbH in the registry?
The most recently registered devices listed for Bebig Isotopentechnik GmbH include ISOSEED PD-103.