Summary
The FDA issued a Class II for SlideView VS200 slide viewer, by EVIDENT SCIENTIFIC INC. Reason: A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cabl.
Details
Source
Device Recall
External ID
Z-2416-2024
Action Date
2024-08-07
Status
Ongoing
Category
device
Product Description
SlideView VS200 slide viewer,
Lot/Code Info: 65159 67105 67104 69153 67106 69154
Quantity Affected: N/A
Reason for Recall
A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This short circuit was caused by a badly positioned cable that made contact with the housing/frame and caused a short circuit and destroyed the fuse in the laser. This caused the shutter to remain in its most recent state; either in an open or closed position. Once the fuse was destroyed the shutter could not be operated.
Distribution
US
Type: FDA Mandated
Recall Initiated: 2024-07-22
Company
Waltham, MA
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 107 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 (EVIDENT SCIENTIFIC INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EVIDENT SCIENTIFIC INC have FDA actions?
This is the only FDA action we have on record for EVIDENT SCIENTIFIC INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2416-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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