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EVIS EXERA III COLONOVIDEOSCOPE recallZ-1213-2024 · Olympus Corporation of the Americas · initiated Jan 11, 2024

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 Olympus Corporation of the Americas 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 repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.

FDA root cause category: Nonconforming Material/Component

What the company is doing

On January 11, 2024, the firm notified customers of the issue via URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect your inventory and identify any products of the model and lots subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and stop using the device. Customers were given detailed instructions on how to identify affected product. Our Olympus Customer Solutions team will contact you to arrange a no-charge return, and a loaner as necessary. Olympus will perform an inspection of your device, repair the variable stiffness mechanism if required, and return your device at no charge to you. Please acknowledge receipt of this matter through the recall portal at https://olympusamerica.com/recall, Enter the recall number "0437" and complete the form as instructed. Customers who have further distributed product should notify downstream accounts at once. Please report to Olympus any adverse events and/or irregularities with the use of the devices by contacting the Olympus Technical Assistance Center at 1- 800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have questions about this recall, please contact the recalling firm at (647) 999-3203 or by e-mail at [email protected].

Recall details

Recall number
Z-1213-2024
Status
Open, Classified
Initiated by the company
Jan 11, 2024
Posted by the FDA
Feb 29, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
28
Product code
NWB
FDA submissions
K192793
Distribution
US Nationwide distribution.

Product description

Colonoscope, Model Number PCF-HQ190L.

Code information (models, lots, serial numbers)

Model Number: PCF-HQ190L; UDI DI: 4953170416118; Serial Number: 2000569, 2001007, 2101185, 2101301, 2101313, 2101860, 2102339, 2102634, 2102740, 2103215, 2103257, 2103483, 2103614, 2103674, 2203899, 2203915, 2204096, 2204400, 2204659, 2204820, 2205238, 2205684, 2206065, 2206501, 2307200, 2307709, 2307713, 2308226;

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

3 devices cleared under K192793 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 93832).

Sources and updates

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