FDA Enforcement
Class II
Ongoing
SlideView VS200 slide viewer,
Recall: Z-2416-2024
·
Reported August 7, 2024
Enforcement
- Recall Number
- Z-2416-2024
- Event ID
- 95028
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- EVIDENT SCIENTIFIC INC
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- N/A
- Report Date
- August 7, 2024
- Initiation Date
- July 22, 2024
- Classification Date
- July 26, 2024
- Address
- 48 Woerd Ave, N/A, Waltham, MA, 02453-3826, United States
Description
SlideView VS200 slide viewer,
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 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.
Code Info
65159 67105 67104 69153 67106 69154
Distribution
US
Quantity
N/A