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U.S. Department of Health and Human Services

Class 2 Device Recall Prolieve

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  Class 2 Device Recall Prolieve see related information
Date Initiated by Firm July 19, 2004
Date Posted August 11, 2004
Recall Status1 Terminated 3 on March 31, 2005
Recall Number Z-1339-04
Recall Event ID 29633
PMA Number P030006 
Product Classification System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
Product Prolieve¿ Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***
Code Information CEL0204AK CEL0204BK CEL0204CK CEL0204DK CEL0204EK CEL0204FK CEL0204GK CEL0204HK CEL0204IK CEL0204JK CEL0604AK CEL0604BK CEL0604CK CEL0604DK CEL0604EK CEL0604FK CEL0604GK CEL0604HK CEL0604IK CEL0604JK CEL0604KK CEL0604LK CEL0604MK CEL0604NK CEL0604OK CEL0604PK CEL1904AK CEL1904BK 
Recalling Firm/
Celsion Corporation
10220 Old Columbia Rd Ste L
Columbia MD 21046-2364
For Additional Information Contact Marie Peters
Manufacturer Reason
for Recall
Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
FDA Determined
Cause 2
Action Celsion Corporation ceased distribution of the device 6/25/04 and implemented a field correction by company representatives at end user facilities on 6/25/04 consisting of computer clock reset. The firm subsequently notified end users on 7/19/04 by certified letter, which included a warning sticker to be placed on the device control screen. The notification and sticker instructed users not to use the device if there is a possibility of the computer clock transitioning through midnight during the procedure.
Quantity in Commerce 28 devices
Distribution Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.
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.
PMA Database PMAs with Product Code = MEQ and Original Applicant = MEDIFOCUS, INC