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U.S. Department of Health and Human Services

Class 2 Device Recall Raymond Corporation ForkTip Laser Guide

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  Class 2 Device Recall Raymond Corporation ForkTip Laser Guide see related information
Date Initiated by Firm November 28, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3
Recall Number Z-0484-2012
Recall Event ID 60528
Product Classification Alignment laser product - Product Code RER
Product Raymond Laser alignment guide - Model #1096597/001 Green Laser.

Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.
Code Information Model #1096597/001
Recalling Firm/
Manufacturer		 The Raymond Corporation
S Canal St
Greene NY 13778-1281
Manufacturer Reason
for Recall		 Raymond shipped a laser alignment guide as an option on its powered industrial trucks from February 2, 2010 through April 21, 2011, but was not aware of its obligation under 21 C.F.R. 1010.2 and 1010.3 to certify and label.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Raymond will be initiating a Field Campaign to ensure that all customers with Alignment Guides have the confirmatory laser caution decals and manufacturer label, an updated installation and service manual, the operator instructions, and informational brochure. This campaign will be performed at no cost to Raymond's dealers and customers, and will include documenting the laser serial number for each truck configured with an Alignment Guide for product traceability.
Quantity in Commerce 493 total
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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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