Mar

2004

Inc Class II Coherent

Company: Coherent, Inc.
Date of Enforcement Report: 3/3/04
Class: II

PRODUCT
Quattro FAP System, Class IV multi-wavelength laser diode material processing machine. Recall # Z-0357-04.

REASON
Performance requirement-safety interlocks malfunction due to improper information included in the software operating the laser

CODE
None.

RECALLING FIRM/MANUFACTURER
Coherent, Inc, Santa Clara, CA, by technician visit to install software, by February 29, 2004. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
52 units.

DISTRIBUTION
Nationwide.

About the author

Amy Sellers

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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Inc Class II Coherent

Amy Sellers

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