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Full HD Visualization Endoscopic Image Processor

Scivita Medical Technology Co., Ltd. · Model HDVS-S300B · UDI-DI 06971381252408

EOQ Prescription

510(k) clearances

33,128

Adverse events (209 deaths)

160

Recalls

191

Facilities

Description

The product is composed of full HD visualization endoscopic image processor, power supply adapter and power cables. This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

Recalls

Date	Firm	Reason
2026-01-29	Olympus Corporation of the Americas	Potential for rubber fragment detachment during use.
2026-01-29	Olympus Corporation of the Americas	Potential for rubber fragment detachment during use.
2026-01-21	Auris Health, Inc	Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application w
2025-12-04	Intuitive Surgical, Inc.	Due to probe bags that may have a compromised or incomplete sterile pouch seal.
2025-09-12	Noah Medical Corporation	Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
2025-09-11	Olympus Corporation of the Americas	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency
2025-09-11	Olympus Corporation of the Americas	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency
2025-09-11	Olympus Corporation of the Americas	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency
2025-09-11	Olympus Corporation of the Americas	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency
2025-09-11	Olympus Corporation of the Americas	Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency

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Data 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.