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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed 12it

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  Class 2 Device Recall GammaMed 12it see related information
Date Initiated by Firm September 11, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on May 18, 2007
Recall Number Z-0487-2007
Recall Event ID 36304
Product Classification radionuclide applicator system - Product Code JAQ
Product GammaMed 12it radionuclide applicator system, Varian Medical Systems, Palo Alto, CA.
Code Information H630202
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris Street
Suite 109
Charlottesville VA 22903-4584
For Additional Information Contact Mark Kattmann
434-977-8495 Ext. 232
Manufacturer Reason
for Recall		 Medical device for patient treatment does not meet electrical safety standards.
FDA Determined
Cause 2		 Other
Action The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.
Quantity in Commerce 1 unit
Distribution Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
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.
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