Z-2989-2011

INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG...

Name: Z-2989-2011 INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG...
Creator: Carl Zeiss Meditec, Inc.
Published: 2011-07-01
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2011-07-01 / Terminated / root cause: manufacturing process

FDA source

Carl Zeiss Meditec, Inc. began a recall of INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments on 2011-07-01. The reason FDA records is "Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol". 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-2989-2011
Status: Terminated
Initiated: 2011-07-01
Posted: 2011-08-10
Terminated: 2011-10-13
Recalling firm: Carl Zeiss Meditec Inc
Product: INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.
Product code: JAD System, Therapeutic, X-Ray
Reason for recall: Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Carl Zeiss Meditec, Inc. sent an "Important Field Correction Action" letter dated July 13, 2011 to all affected customers. The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844.
Quantity in commerce: 8 boxes of 10 sterile packages.
Distribution: Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.
Product codes and lots: Lot 110851; Catalog number 304534-6000-585.

Product code JAD

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)