Coherent Inc Laser Group Class I

Company: Coherent Inc Laser Groups
Date of Enforcement Report: 3/24/04
Class: I

PRODUCT
Coherent brand Quattro Diode Laser Systems; A Quattro FAP System. Recall # Z-0357-04.

REASON
Software problem that may cause the instrument to remain on and emitting laser radiation after the interlock has been activated.

CODE
Serial Numbers/Model Numbers: TFAP0004P-TFAP00048.

RECALLING FIRM/MANUFACTURER
Coherent Inc Laser Group, Santa Clara, CA, by letter and on-site visit on November 7, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
52 units.

DISTRIBUTION
Nationwide.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.