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Terminated

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

FDA Recall Z-0516-2013 · Posted 2013-01-30

Recalling FirmMotorola Inc
Recall StatusTerminated
Product CodeRFZ
Date Initiated2012-04-27
Date Terminated2018-06-29
Product Quantity16,961 units domestically

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.

Firm 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.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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