FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec, Inc.: INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Recall number
- Z-0405-2013
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Product
- INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
- Status
- Terminated
- Initiated
- 2012-10-25
- Posted
- 2012-11-20
- Terminated
- 2012-11-20
- Reason
- A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Root cause
- Nonconforming Material/Component
- Action
- Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc. A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product. For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com. For questions regarding this recall call 925-557-4616.
- Quantity
- 36 total, all lots
- Distribution
- Nationwide Distribution including IL and MD
- Lot, serial or model codes
- Part number 304534-7500-001; lot number 540959.
- 510(k) numbers
- ["K090584"]
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 2918630
- Firm city
- Dublin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28