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3D Visualization System
Scivita Medical Technology Co., Ltd. · Model 3DVS-S100A · UDI-DI 06971381250015
GCJ
Prescription
1
510(k) clearances
84,850
Adverse events (262 deaths)
274
Recalls
568
Facilities
Description
The product is composed of a host, a foot switch and HD-SDI data cables, HDMI-DVI data cables (Foot switch, HD-SDI data cables and HDMI-DVI data cables are optional). This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-07 | Olympus Corporation of the Americas | Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. |
| 2025-12-11 | Applied Medical Resources Corp | There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-09-24 | Aesculap Inc | It was determined there is the potential of silicone fragments detaching from the yellow sealing component. |
| 2025-06-18 | Stryker Corporation | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2024-06-25 | UNIMAX MEDICAL SYSTEMS INC | The tube may fall into the surgical site during the grasping process. |
| 2024-06-11 | Canadian Hospital Specialties Ltd. | A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint. |
| 2024-06-03 | ASPEN SURGICAL | The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.