18
Feb
2012

Cl ll Volcano pcFM Software Kit

0

Company:Volcano Corp.
Date of Enforcement Report 2/15/12
Class ll:

PRODUCT
Volcano pcFM Software Kit. 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. Model 6830 ComboMap Software kit; Kit. Recall # Z-0973-2012

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.

RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letter dated June 17, 2010. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
8 units

DISTRIBUTION
Nationwide, The Netherlands, Sweden and United Kingdom

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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