INTRABEAM® Spherical Applicator 1.5 cm 304534-6000-557Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K121653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 1, 2026Class IIOpen, Classified

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

   Z-2649-2026 · Root cause: Employee error · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121653. One submission often covers many models, so check the product and lot details in each record.

• Z-0001-2018 · Aug 30, 2017 · Terminated
  Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy