🟡
Class II
May cause reversible problems
🩺Dispositivo médico#Z-2649-2026
Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
What happened?
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
What should I do now?
- 1Check the lot number on your product packaging.
- 2If you have it, stop using it.
- 3Return it to your pharmacy or store for a refund.
- 4If you already used it and feel unwell, see your doctor immediately.
- 5Report adverse effects to the FDA: 1-800-FDA-1088.
- Company
- Carl Zeiss Meditec AG
- Status
- Ongoing
- Report date
- 2026-07-08
- Initiated
- 2026-06-01
- 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
This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.