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U.S. Department of Health and Human Services

Class 2 Device Recall INTRABEAM Shielding Material

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  Class 2 Device Recall INTRABEAM Shielding Material see related information
Date Initiated by Firm July 01, 2011
Date Posted August 10, 2011
Recall Status1 Terminated 3 on October 13, 2011
Recall Number Z-2989-2011
Recall Event ID 59362
510(K)Number K090584  K051055  
Product Classification Therapeutic X-ray System - Product Code JAD
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.
Code Information Lot 110851; Catalog number 304534-6000-585.
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec, Inc.
5160 Hacienda Dr
Dublin CA 94568-7562
For Additional Information Contact
925-557-4616
Manufacturer 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,
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAD and Original Applicant = CARL ZEISS SURGICAL GMBH
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