Volcano pcFM Software Kit ; Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624. The volca

FDA device recall Z-0973-2012 · posted 2012-02-07 · Terminated

Recall details

Recalling firm

Volcano Corporation

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

IYO

Quantity affected

8 units

Distribution

Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.

Date initiated

2010-06-11

Date posted

2012-02-07

Date terminated

2012-02-07

Location

Rancho Cordova, CA