Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0516-2013Class II

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

Motorola Inc / initiated 2012-04-27 / Terminated / root cause: labeling and UDI

Motorola Inc began a recall of Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0516-2013
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Motorola Inc
Product
Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
Product code
RFZ Upc Scanner Reader (Bar Code Reader)
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.
Root cause tag
labeling and UDI
FDA root cause
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
Product codes and lots
Motorola Solutions PCS3000/CS3070 Laser

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0516-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0516-2013Class IITerminatedVoluntary: Firm initiated