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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0516-2013 | Class II | Terminated | Voluntary: Firm initiated |
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