Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Official details
- Category
- Medical device recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Carl Zeiss Meditec AG
- Affected product
- 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.
- Risk or reason
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Remedy or action
- UDI: (01)04049539101563 Batch no: A0002 Serial numbers: US - A63141, A63086 OUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, A6313
- Official ID
- Z-2649-2026