Events

Recall of Device Recall Perseus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lockheed-Martin Aculight.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    54087
  • Event Risk Class
    Class 2
  • Event Number
    Z-1170-2010
  • Event Initiated Date
    2009-05-01
  • Event Date Posted
    2010-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87457
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    general purpose laser products - Product Code RDW
  • Reason
    Defect of optical fiber - the perseus device with type "b" fiber has been found to emit potentially hazardous laser radiation.
  • Action
    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.

Device

Device Recall Perseus
  • Model / Serial
    Part Number: 35-001466-032, Corresponding Unit Serial Numbers: 00001,00002, and 00003.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada.
  • Product Description
    LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defective type"A" fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Lockheed Martin Aculight, Bothell, WA, 98021. || Pulsed laser energy generator intended for use as an OEM component for the LiDAR/Rangefinding, Surveillance, Mapping, and Sensing.
  • Manufacturer
    Lockheed-Martin Aculight

Manufacturer

Lockheed-Martin Aculight
  • Manufacturer Address
    Lockheed-Martin Aculight, 22121-20th Ave SE, Bothell WA 98021
  • Manufacturer Parent Company (2017)
    Lockheed Martin Corporation
  • Source
    USFDA