FDA Medical Device Recalls (openFDA)
Wescam Inc: 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 number
- Z-0172-2010
- 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.
- Status
- Terminated
- Initiated
- 2009-08-01
- Posted
- 2009-12-16
- Terminated
- 2013-01-15
- Reason
- Products do not comply with 21 CFR 1040.11.
- 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
- 306 total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Only model numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- RET
- Firm FEI
- 3000173214
- Firm city
- Canada
- Firm state
- Ontario
- 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