Summary
The FDA issued a Class II for RAPTAR Laser Range Finders by Potomac River Group, Corp.. Reason: RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator..
Details
Source
Device Recall
External ID
Z-0001-2022
Action Date
2021-11-03
Status
Ongoing
Category
device
Product Description
RAPTAR Laser Range Finders
Lot/Code Info: RAPTAR G02 (Wilcox Part #57200G02)
Quantity Affected: 62 units
Reason for Recall
RAPTAR units are capable of being field modified to enable the use of the higher power visible and IR laser pointers and the IR Illuminator.
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-21
Company
Ashburn, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Potomac River Group, Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Potomac River Group, Corp. have FDA actions?
This is the only FDA action we have on record for Potomac River Group, Corp. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0001-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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