Colonoscope, Model Number PCF-HQ190L.
This recall is currently active, issued February 29, 2024. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- January 11, 2024
- Posted
- February 29, 2024
- Recall Number
- Z-1213-2024
- Quantity
- 28
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide distribution.
Lot / Code Info
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;
Root Cause
Nonconforming Material/Component
Action Taken
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 Cynthia.Ow@Olympus.com.