Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0172-2010

MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15...

Wescam Inc / initiated 2009-08-01 / Terminated

Wescam Inc began a recall of 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 on . The reason FDA records is "Products do not comply with 21 CFR 1040.11". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0172-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wescam Inc
Product
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.
Product code
RET Laser Target Designator
Reason for recall
Products do not comply with 21 CFR 1040.11.
FDA root cause
Radiation Control for Health and Safety Act
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.
Quantity in commerce
306 total
Distribution
Nationwide Distribution
Product codes and lots
Only model numbers.