LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defectiv

FDA device recall Z-1170-2010 · posted 2010-04-12 · Terminated

Recall details

Recalling firm

Lockheed-Martin Aculight

Reason for recall

Defect of optical fiber - The Perseus device with type "B" fiber has been found to emit potentially hazardous laser radiation.

Action taken

A Radiation Warning Notification was sent to all customers. The notification stated the purpose and problem. In addition, a Notification of Potential Perseus Laser Safety Issue letter was sent to the only customer who received the defective type "B" fiber product. The letter identified the affected product and stated that the product was not considered eye-safe. The firm recommended that the customer cease using the laser with the Part Number: 35-001466-032 and Corresponding Unit Serial Numbers: 00001,00002, and 00003. The customer is to return the affected product for additional testing and warranty repair. Questions should be directed to Rick Whitty on 425-482-1100 or at Richard.j.whitty@lmco.com.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

RDW

Quantity affected

3

Distribution

Worldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada.

Date initiated

2009-05-01

Date posted

2010-04-12

Date terminated

2012-04-30

Location

Bothell, WA