Recall Z-0405-2013 ยท JAD System, Therapeutic, X-Ray
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.
| Date | Nov 20, 2012 (initiated Oct 25, 2012) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090584 | INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS Carl Zeiss Surgical GmbH, Nov 24, 2009 |