Olympus recalls colonoscopes with model PCF-HQ190L that may fail due to improper assembly without vibration and temperature protection. Affected units have specific serial numbers and UDI codes.
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.
Olympus is recalling colonoscopes with model PCF-HQ190L that were assembled without a protective adhesive. This could cause the device to fail under normal use conditions like vibration, temperature changes, or shocks.
The colonoscope lacks an adhesive that protects it from physical stresses such as vibration, temperature fluctuations, or severe shocks. This could lead to the device failing during medical procedures, potentially causing injury or inaccurate results.
Medical professionals who use the colonoscope during procedures are most at risk. Patients using the device for diagnostic purposes may also be affected if the device fails during use.
Check for the model number PCF-HQ190L on the device. Affected units have specific serial numbers listed in the recall notice, including 2000569, 2001007, and others.
Look for the model number PCF-HQ190L on the colonoscope to confirm if it is affected.
Reach out to Olympus Corporation of the Americas for further assistance or to confirm if your device is affected.
The colonoscope was assembled without an adhesive that protects it from physical stresses like vibration, temperature changes, or shocks, which could cause failure during use.
The affected model is PCF-HQ190L with specific serial numbers listed in the recall notice.
Check for the model number PCF-HQ190L and compare the serial number to the list provided in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1213-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1213-2024 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
