Recall Z-0973-2012 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
| Date | Feb 7, 2012 (initiated Jun 11, 2010) |
| Status | Terminated |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.