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EVIS EXERA III COLONOVIDEOSCOPE recallZ-0418-2024 · Aizu Olympus Co., Ltd. · initiated Oct 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aizu Olympus Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

FDA root cause category: Process control

What the company is doing

On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or [email protected].

Recall details

Recall number
Z-0418-2024
Status
Open, Classified
Initiated by the company
Oct 16, 2023
Posted by the FDA
Nov 29, 2023
Recalling firm
Aizu Olympus Co., Ltd.
Quantity
24 incorrectly repaired units
Product code
FDF
FDA submissions
K131780
Distribution
Domestic distribution to FL, KY, MA, NJ, NY, and PA

Product description

PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

Code information (models, lots, serial numbers)

UDI-DI 04953170363672 Serial Numbers 2942716, 2604497, 2502056

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

22 devices cleared under K131780 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93335).

Sources and updates

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