27
Feb
2006

Inc. Class II Lumenis

0

Company: Lumenis, Inc.
Date of Enforcement Report:2/22/2006
Class:lI

PRODUCT
Lumenis brand Lumenis One System with Multi-Spot Nd: YAG, LightSheer and Universal IPL, Recall # Z-0529-06

REASON
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.

CODE
Software versions lower than 2.02. All serial numbers; All codes

RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumenis, Inc., Santa Clara, CA, by letters on April 8, 2005.
Manufacturer: Lumenis, Ltd., Yokneam, Israel. Firm initiated recall is complete

VOLUME OF PRODUCT IN COMMERCE
142 units

DISTRIBUTION
Nationwide and New Zealand

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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