Cl ll Volcano s5/s5i imaging system Family

Company:Volcano Corp.,
Date of Enforcement Report 12/8/2010
Class ll:

PRODUCT
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011

REASON
Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.

RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letter dated June 30, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
79 units

DISTRIBUTION
Nationwide, and the countries of France, Germany, Japan, and the UK

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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