Date Initiated by Firm |
September 11, 2006 |
Date Posted |
January 11, 2007 |
Recall Status1 |
Terminated 3 on May 18, 2007 |
Recall Number |
Z-0486-2007 |
Recall Event ID |
36304 |
510(K)Number |
K912555 K891131
|
Product Classification |
radionuclide applicator system - Product Code JAQ
|
Product |
GammaMed 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 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 |
31 total units |
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
|
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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 = JAQ and Original Applicant = MICK RADIO-NUCLEAR INSTRUMENTS, INC. 510(K)s with Product Code = JAQ and Original Applicant = RTS TECHNOLOGY, INC.
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