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U.S. Department of Health and Human Services

Class 2 Device Recall Perseus

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 Class 2 Device Recall Perseussee related information
Date Initiated by FirmMay 01, 2009
Date PostedApril 12, 2010
Recall Status1 Terminated 3 on April 30, 2012
Recall NumberZ-1170-2010
Recall Event ID 54087
Product Classification general purpose laser products - Product Code RDW
ProductLM 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.
FEI Number 3003346474
Recalling Firm/
Manufacturer		 Lockheed-Martin Aculight
22121-20th Ave SE
Bothell WA 98021
Manufacturer Reason
for Recall		Defect of optical fiber - The Perseus device with type "B" fiber has been found to emit potentially hazardous laser radiation.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
ActionA 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 Commerce3
DistributionWorldwide Distribution -- USA, including states of PA, FL, MD, & CO and the countries of Austria and Canada.
Total Product Life CycleTPLC Device Report
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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