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U.S. Department of Health and Human Services

Class 2 Device Recall pcFM Software Kit

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  Class 2 Device Recall pcFM Software Kit see related information
Date Initiated by Firm June 11, 2010
Date Posted February 07, 2012
Recall Status1 Terminated 3 on February 07, 2012
Recall Number Z-0973-2012
Recall Event ID 60867
Product Classification ComboMap System pcFM - Product Code IYO
Product Volcano pcFM Software Kit ;
Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624.

The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data.
Code Information Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
Recalling Firm/
Manufacturer		 Volcano Corporation
2870 Kilgore Rd
Rancho Cordova CA 95670-6133
For Additional Information Contact Neil O'Connor
916-281-2790
Manufacturer Reason
for Recall		 Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action The firm, Volcano Corporation, sent an "IMPORTANT PRODUCT INFORMATION" letter dated June 17, 2010 to all customers. The letter describes the product, problem and actions to be taken. The customers were instructed to return the pcFM Software kit to: Volcano Corporation at 2870 Kilgore Road, Rancho Cordova, CA 95670 and contact (800) 228-4728 for instructions on returning the product. The customers were also instructed to complete and return the attached Customer Reply Letter form to Volcano even if they no longer use the pcFM Software Kit via fax to Volcano Customer Support at (916) 638-8812. If you have any questions, contact your Sales Representative or Customer Service at (800) 228-4728.
Quantity in Commerce 8 units
Distribution Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
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.
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