Z-2316-2018Class II

MX-10 surveillance laser system

Name: Z-2316-2018 MX-10 surveillance laser system
Creator: Wescam Inc
Published: 2018-05-08
License: https://open.fda.gov/license/

Wescam Inc / initiated 2018-05-08 / Terminated

FDA source

Wescam Inc began a recall of MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff... on 2018-05-08. FDA classified it as Class II and gives the reason as "Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2316-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-08
Posted: 2018-07-15
Terminated: 2021-08-24
Recalling firm: Wescam Inc
Product: MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
Product code: REP Surveying Laser Product
Reason for recall: Product has a nominal ocular hazard distance (NOHD) that is longer than specified and persons could be exposed to light in excess of the exposure limit.
FDA root cause: Radiation Control for Health and Safety Act
Action: Firm sent a Service Bulletin dated June 2018 to customers. The Bulletin identified the affected product, problem and actions to be taken. For question call 888-5-WESCAM or email [email protected].
Quantity in commerce: 29
Distribution: US Nationwide Distribution
Product codes and lots: L3 Wescam MX-10, part numbers 44620-203, 44620-211, 44620-213, 44620-215, 44620-221,4620-258, 44620-263, 44620-277, 45840-13, 45840-20, and 45840-23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2316-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2316-2018	Class II	Terminated	FDA Mandated	2018-07-25	2018-07-15

Product code REP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)