Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2649-2026

June 01, 2026

Class II

Product summary

Firm
Carl Zeiss Meditec AG
Event
Event 99239
Status
Ongoing
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-2649-2026

Official wording

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

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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