Recall Z-2316-2018— Wescam Inc
Class II · Terminated
Class II FDA medical device recall by Wescam Inc, initiated 2018-05-08, terminated 2021-08-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Wescam Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-08
- Terminated
- 2021-08-24
- Firm location
- Burlington, Ontario, Canada
Product description
MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.