Atlas FDA

Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing material handli

FDA device recall Z-0485-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm
The Raymond Corporation
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.
Action taken
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.
Root cause
Radiation Control for Health and Safety Act
Status
Terminated
Product code
RER
Quantity affected
493 total
Distribution
Nationwide Distribution
Date initiated
2011-11-28
Date posted
2012-01-11
Location
Greene, NY

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