| Date Initiated by Firm | August 01, 2009 |
|---|
| Date Posted | December 16, 2009 |
|---|
| Recall Status1 |
Terminated 3 on January 15, 2013 |
| Recall Number | Z-0172-2010 |
|---|
| Recall Event ID |
53809 |
| Product Classification |
Laser Target Designator - Product Code RET
|
| 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. |
|---|
| Code Information |
Only model numbers. |
| FEI Number |
3000173214
|
Recalling Firm/
Manufacturer |
Wescam Inc
649 North Service Road West
Burlington Canada Ontario
|
Manufacturer Reason
for Recall | Products do not comply with 21 CFR 1040.11. |
|---|
FDA Determined
Cause 2 | 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 |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
