Carl Zeiss Meditec AG: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

Hazard

Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

Details from the source

Reason for recall: Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. 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. Quantity: 13 units Lot/code info: 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

UPC codes

04049539101563

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.