ClearanceBrief
Recall Z-0516-2013 ยท RFZ Upc Scanner Reader (Bar Code Reader)

Motorola Inc

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

DateJan 30, 2013 (initiated Apr 27, 2012)
StatusTerminated
ReasonIt 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.
Root causeRadiation Control for Health and Safety Act
ActionMotorola 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 noti
Quantity16,961 units domestically
DistributionNationwide distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.