FDA Recall
Terminated
MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.
Recall: Z-0172-2010
·
Initiated August 1, 2009
Recall
- Recall Number
- Z-0172-2010
- Event Number
- 53809
- Firm
- Wescam Inc 649 North Service Road West Burlington Canada Ontario
- FEI Number
- 3000173214
- Product Code
- RET
- Status
- Terminated
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- August 1, 2009
- Posted
- December 16, 2009
- Terminated
- January 15, 2013
Description
MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.
Reason
Products do not comply with 21 CFR 1040.11.
Action
L-3 Wescam has issued notification of the MX Series Products describing a non-compliance with 1040.11(b). The notice instructs customers to refrain from using the infrared laser illuminator, based on a serious eye hazard from viewing the direct or reflected laser emission. Products will be repaired or removed if they cannot be repaired and a refund will be implemented.
Distribution
Nationwide Distribution
Quantity
306 total