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U.S. Department of Health and Human Services

Class 2 Device Recall GammaMed 12i

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 Class 2 Device Recall GammaMed 12isee related information
Date Initiated by FirmSeptember 11, 2006
Date PostedJanuary 11, 2007
Recall Status1 Terminated 3 on May 18, 2007
Recall NumberZ-0486-2007
Recall Event ID 36304
510(K)NumberK891131 K912555 
Product Classification radionuclide applicator system - Product Code JAQ
ProductGammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
Code Information H630701 H630703 H630704 H630705 H630706 H630708 H630710 H630711 H630712 H630713 H630714 H630715 H630716 H630718 H630719 H630720 H630721 H630722 H630723 H630724 H630725 H630727 H630728 H630729 7H63030 H630732 H630733 H630735 H630736 H630737 H630739
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris Street
Suite 109
Charlottesville VA 22903-4584
For Additional Information ContactMark 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
ActionThe 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 Commerce31 total units
DistributionWorldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAQ
510(K)s with Product Code = JAQ
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