Bf 240/P240/IT240 Bronchovideoscope & Accessories

• 2 recalls, same reason

  • Ongoing Z-0337-2024 FDA Class II ·initiated 25 Sep 2023
  • 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-2503-2023 FDA Class II ·initiated 27 Jul 2023

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

• 3 recalls, same reason

  • Terminated Z-3289-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3298-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3286-2018 FDA Class II ·initiated 8 Aug 2018

  The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

510(k) Number

K963033 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• 3D Surgical Endoscopy System for General Surgery

  Class II

  FDA 510(k) K943307 Active Cleared 20 Dec 1995

• Olympus Fg-45/46-1 Grasping Forceps

  Class II

  FDA 510(k) K955049 Active Cleared 15 Dec 1995

• Olympus Unsaturated Iron Binding Capacity Reagent

  Class I

  FDA 510(k) K955139 Active Cleared 12 Feb 1996

• Olympus Fb Series Biopsy Forceps

  Class II

  FDA 510(k) K962555 Active Cleared 30 Jul 1996

• Olympus Fd-5 Hot Biopsy Forceps

  Class II

  FDA 510(k) K951445 Active Cleared 3 May 1995

• Olympus Biopsy Forceps Model Fb-44

  Class II

  FDA 510(k) K950786 Active Cleared 6 Mar 1995

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