Device product
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Z-0405-2013
Product summary
- Event
- Event 63596
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 total, all lots
- Official record key
device-enforcement:Z-0405-2013
Official wording
Reason: A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
Code information: Part number 304534-7500-001; lot number 540959.
Distribution pattern: Nationwide Distribution including IL and MD
Derived failure modes
-
Manufacturing or process control
manufacturing defect