Zeiss Intrabeam Spherical Applicator failed manufacturing specifications
Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is manufacturing non-compliance without evidence of resulting harm. This matches FDA Class II without reported adverse events, which typically rates 2 (Moderate).
Plain-English summary
Zeiss Intrabeam Spherical Applicator 1.5 cm (Model REF: 304534-6000-557) units manufactured by Carl Zeiss Meditec AG are being recalled because they failed to meet manufacturing specifications. This is a radiation therapy accessory device.
A total of 13 units have been distributed worldwide. In the United States, the affected units were distributed in Florida and Puerto Rico. International distribution includes China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
The recalled units are identified by UDI (01)04049539101563, Batch number A0002. In the US, serial numbers affected are A63141 and A63086. Outside the US, the affected serial numbers are A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110, A63112, and A6313.
Patients or healthcare providers in possession of affected units should contact Carl Zeiss Meditec AG for instructions on the appropriate course of action.
The recalled product
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Manufacturer
- Carl Zeiss Meditec AG
- Hazard
- manufacturing-defect
- specification-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distributed nationwide across the United States.
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