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U.S. Department of Health and Human Services

Class 2 Device Recall Rita

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  Class 2 Device Recall Rita see related information
Date Initiated by Firm September 21, 2005
Date Posted October 07, 2005
Recall Status1 Terminated 3 on January 03, 2006
Recall Number Z-0031-06
Recall Event ID 33623
510(K)Number k051420  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;

Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Code Information Lot Number: 0011
Recalling Firm/
Manufacturer		 Rita Medical Systems
46421 Landing Parkway
Fremont CA 94538
For Additional Information Contact Linda Guthrie
510-771-0440
Manufacturer Reason
for Recall		 Devices for which sterility may be compromised as evidenced by a loss of package integrity.
FDA Determined
Cause 2		 Other
Action On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Distribution Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
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 = GEI and Original Applicant = EMCISION, LTD.
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