FDA Medical Device Recalls (openFDA)
Motorola Inc: Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
- Recall number
- Z-0516-2013
- Recalling firm
- Motorola Inc
- Product
- Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products
- Status
- Terminated
- Initiated
- 2012-04-27
- Posted
- 2013-01-30
- Terminated
- 2018-06-29
- Reason
- 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
- 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
- 16,961 units domestically
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Motorola Solutions PCS3000/CS3070 Laser
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RFZ
- Firm FEI
- 3014423912
- Firm city
- Holtsville
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28