Recall Z-0516-2013— Motorola Inc

Name: FDA recall Z-0516-2013
Creator: U.S. Food and Drug Administration
Published: 2012-04-27

Class II · Terminated

Class II FDA medical device recall by Motorola Inc, initiated 2012-04-27, terminated 2018-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products. 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..

Recalling firm: Motorola Inc
Classification: Class II
Status: Terminated
Initiated: 2012-04-27
Terminated: 2018-06-29
Firm location: Holtsville, NY, United States

Product description

Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.