Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Summary
The FDA issued a Class II for Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V by YAMAHA MOTOR CORPORATION. Reason: Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certi.
Details
Source
Device Recall
External ID
Z-1816-2024
Action Date
2024-05-29
Status
Ongoing
Category
device
Product Description
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Lot/Code Info: Model YRi-V, YSi-V, YSi-V(HS2)
Quantity Affected: 67
Reason for Recall
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. ¿ 1010.2 in that they currently do not bear the required certification label.
Distribution
US Nationwide
Type: FDA Mandated
Recall Initiated: 2024-04-17
Company
Marietta, GA
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 291 device recalls issued in the same week, part of 403 device-related FDA actions this month.
YAMAHA MOTOR CORPORATION has 2 FDA actions in our database, including 2 recalls.
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 (YAMAHA MOTOR CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does YAMAHA MOTOR CORPORATION have FDA actions?
YAMAHA MOTOR CORPORATION has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1816-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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