Carl Zeiss Meditec Ag: System, Therapeutic, X-ray
Recall Summary Zeiss Intrabeam Spherical Applicator 1.5 cm devices (model REF:304534-6000-557) used in radiation therapy are being recalled because they do not meet manufacturing specifications. The affected devices were distributed nationwide in the US, plus Puerto Rico, and internationally in China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
- Recalling firm
- Carl Zeiss Meditec AG
- Product
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
- Reason
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f6014636-fe10-4f3b-9106-4625e36ce08f