Olympus Lf-Tp and Lf-Dp Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment

• • Ongoing Z-0557-2024 FDA Class II ·initiated 28 Sep 2023

  Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

• 3 recalls, same reason

  • Ongoing Z-0338-2024 FDA Class II ·initiated 25 Sep 2023
  • Ongoing Z-0344-2024 FDA Class II ·initiated 25 Sep 2023
  • Ongoing Z-0332-2024 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-2504-2023 FDA Class II ·initiated 27 Jul 2023

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

510(k) Number

K981543 ↗

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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  FDA 510(k) K011149 Active Cleared 15 May 2001

• XBO1-824-18/19/20 Biopsy Forceps

  Class II

  FDA 510(k) K012074 Active Cleared 25 Sep 2001

• Disposable Aspiration Needle Na-200H

  Class II

  FDA 510(k) K023272 Active Cleared 23 Dec 2002

• Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model Xcf-Q140L/13D

  Class II

  FDA 510(k) K002749 Active Cleared 4 Dec 2000

• Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract

  Class II

  FDA 510(k) K001203 Active Cleared 26 May 2000

• Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment

  Class II

  FDA 510(k) K011869 Active Cleared 25 Jul 2001

See all devices from The Olympus Optical Co. →