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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 October 06, 2003
Date Posted November 01, 2003
Recall Status1 Terminated 3 on May 05, 2004
Recall Number Z-0087-04
Recall Event ID 27500
510(K)Number K031926  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product RITA brand ThermoPad, Electrosurgical RF Generator and accessories
Part Number: 700-102649
Code Information Lot numbers: Y072103-3, Y082003
Recalling Firm/
Rita Medical Systems
967 N Shoreline Blvd
Mountain View CA 94043-1932
For Additional Information Contact Erin Mazzone
Manufacturer Reason
for Recall
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
FDA Determined
Cause 2
Action On 10/6/03, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce 137 + 225 units (lot Y082003)
Distribution Product was released for distribution to 66 consignees in US. The product received nationwide distribution. The recall was appropriately extended to the user level; i.e., the hospitals that received the recalled product. There were no shipments to foreign or Canadian distribution, however, it includes one military distribution: Wilford Hall Medical Center, 2200 Berquist Dr., 31, Lackland AFB, TX 78236.
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 = RITA MEDICAL SYSTEMS INC