Z-0406-2013Class II

INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is...

Name: Z-0406-2013 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is...
Creator: Carl Zeiss Meditec, Inc.
Published: 2012-10-25
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2012-10-25 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Meditec, Inc. began a recall of INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments on 2012-10-25. FDA classified it as Class II and gives the reason as "A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0406-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2012-11-20
Terminated: 2012-11-20
Recalling firm: Carl Zeiss Meditec Inc
Product: INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. For questions regarding this recall call 925-557-4616.
Quantity in commerce: 36 total, all lots
Distribution: Nationwide Distribution including IL and MD
Product codes and lots: Part number 304534-7500-002; lot number 540960.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0406-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0404-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20
Z-0405-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20
Z-0406-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code JAD

K090584Class IIIntrabeam System with Balloon Applicator and Cbg SetsCarl Zeiss Surgical GmbH / cleared 2009-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)