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Class 2 Device Recall Perseus |
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Date Initiated by Firm |
May 01, 2009 |
Date Posted |
April 12, 2010 |
Recall Status1 |
Terminated 3 on April 30, 2012 |
Recall Number |
Z-1170-2010 |
Recall Event ID |
54087 |
Product Classification |
general purpose laser products - Product Code RDW
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Product |
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. |
Code Information |
Part Number: 35-001466-032, Corresponding Unit Serial Numbers: 00001,00002, and 00003. |
Recalling Firm/ Manufacturer |
Lockheed-Martin Aculight 22121-20th Ave SE Bothell WA 98021
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Manufacturer Reason for Recall |
Defect of optical fiber - The Perseus device with type "B" fiber has been found to emit potentially hazardous laser radiation.
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FDA Determined Cause 2 |
Radiation Control for Health and Safety Act |
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. |
Quantity in Commerce |
3 |
Distribution |
Worldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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