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U.S. Department of Health and Human Services

Class 2 Device Recall Slide View VS200

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 Class 2 Device Recall Slide View VS200see related information
Date Initiated by FirmJuly 22, 2024
Date PostedJuly 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2416-2024
Recall Event ID 95028
Product Classification Microscopy laser instrument or accessory products - Product Code RIB
ProductSlideView VS200 slide viewer,
Code Information 65159 67105 67104 69153 67106 69154
FEI Number 3023822598
Recalling Firm/
Manufacturer		 EVIDENT SCIENTIFIC INC
48 Woerd Ave
Waltham MA 02453-3826
Manufacturer 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.
FDA Determined
Cause 2		Radiation Control for Health and Safety Act
DistributionUS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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