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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/
Manufacturer		 Rita Medical Systems
967 N Shoreline Blvd
Mountain View CA 94043-1932
For Additional Information Contact Erin Mazzone
650-314-3439
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		 Other
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
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