Evis Exera III Video System

• 5 recalls, same reason

  • Ongoing Z-0063-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0050-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0053-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0060-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0049-2026 FDA Class I ·initiated 11 Sep 2025

  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 therapy equipment.

• • Ongoing Z-0192-2024 FDA Class I ·initiated 12 Oct 2023 ·on shared 510(k) K121959

  There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

• • Ongoing Z-0327-2024 FDA Class II ·initiated 25 Sep 2023

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

• • Ongoing Z-2496-2023 FDA Class II ·initiated 27 Jul 2023

  Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

• 2 recalls, same reason

  • Ongoing Z-2017-2023 FDA Class I ·initiated 8 Jun 2023
  • Ongoing Z-2015-2023 FDA Class I ·initiated 8 Jun 2023

  There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K121959 ↗

FDA product code

EOQ

Device class

Class II

Regulation

21 CFR Part 874.4680

Advisory committee

Ear, Nose, Throat

FDA decision

SESE Substantially Equivalent

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• What is the Evis Exera III Video System used for?

  The Evis Exera III Video System is a universal imaging platform designed for endoscopic and surgical procedures across multiple healthcare specialties, including surgical endoscopy, gastroenterology, urology, and ENT. It supports over 100 different rigid, flexible, and articulating endoscopes and camera heads.

• How is the Evis Exera III Video System supplied?

  The Evis Exera III Video System is supplied as a multi-specialty platform that achieves workflow and cost efficiencies across various medical procedures. It is designed for use in clinical settings and supports compatibility with a wide range of endoscopic instruments.

• What regulatory approvals does the Evis Exera III Video System have?

  The Evis Exera III Video System is authorized under FDA 510K clearance with product code EOQ. It was reviewed by the Ear, Nose, and Throat advisory committee and received a decision code of SESE (Substantially Equivalent) on January 10, 2013.

• What endoscopes are compatible with the Evis Exera III Video System?

  The Evis Exera III Video System supports over 100 different rigid, flexible, and articulating endoscopes and camera heads, providing system compatibility and standardization for greater operating efficiency across various medical specialties.