FDA Medical Device Recalls (openFDA)
Volcano Corporation: 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.
- Recall number
- Z-0973-2012
- Recalling firm
- Volcano Corporation
- 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.
- Status
- Terminated
- Initiated
- 2010-06-11
- Posted
- 2012-02-07
- Terminated
- 2012-02-07
- Reason
- Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
- Root cause
- 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
- 8 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: CA, MI, TX, and WI; and countries of: The Netherlands, Sweden and United Kingdom.
- Lot, serial or model codes
- Model 6830 ComboMap Software kit; Kit P/N #'s: 803259001; 806431005; S2000061, 806431002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYO
- Firm FEI
- 2939520
- Firm city
- Rancho Cordova
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28