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U.S. Department of Health and Human Services

Class 2 Device Recall Motorola Solutions Laser

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  Class 2 Device Recall Motorola Solutions Laser see related information
Date Initiated by Firm April 27, 2012
Date Posted January 30, 2013
Recall Status1 Open3, Classified
Recall Number Z-0516-2013
Recall Event ID 61870
Product Classification Upc reader (bar code reader) - Product Code RFZ
Product Motorola Solutions PCS3000/CS3070 Laser

Utility/Peripheral Laser Products
Code Information Motorola Solutions PCS3000/CS3070 Laser.
Recalling Firm/
Motorola Inc
1 Motorola Plz
Holtsville NY 11742-1300
For Additional Information Contact Mr. Richard Blohm
Manufacturer Reason
for Recall
It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Motorola Solutions, Inc. agrees to provide instructions for downloading and installing a software update from the internet, which will reduce the laser power to IEC Class 1 AELs. Purchasers will be provided an internet site and instructions for notifying Motorola Solutions, Inc. that the software installation and power reduction were successful, thereby completing the corrective action. corrections to all units is anticipated to be completed by May 2013. I. Notifications to all dealers and purchasers must be made, and the FDA NY District Office Recall Coordinator is to be included in the notifications. 2.Correction of all units to be completed by May 2013. 3.All products will be brought into compliance with the laser performance standard at no cost to the purchaser. For questions regarding this recall call 631-738-3474.
Quantity in Commerce 16,961 units domestically
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.