Olympus recalls colonoscopes with model PCF-H190TL due to potential damage from vibration, temperature fluctuations, or shock. Affected units may need repair or replacement.
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.
Olymp: Olympus is recalling colonoscopes with model number PCF-H190TL because they were assembled without proper adhesive protection. This could cause damage from vibration, temperature changes, or shocks during use, potentially affecting the device's reliability.
The colonoscopes were assembled without adhesive that protects against physical stressors like vibration, temperature changes, or shocks. This could lead to device failure during procedures, though serious injury is not typically expected.
Medical professionals who use Olympus colonoscopes with model PCF-H190TL are most likely affected. Patients undergoing procedures with these devices may also be at risk if the equipment fails.
Check for model number PCF-H190TL on the colonoscope. The unique device identifier (UDI) starts with 04953170420702 and serial number 2110150.
Verify the model number, UDI, and serial number on the colonoscope to confirm if it is affected.
The colonoscope was assembled without adhesive that protects against vibration, temperature changes, or shocks, which could cause damage during use.
Check for model number PCF-H190TL, UDI starting with 04953170420702, and serial number 2110150.
No specific stop-use instruction is provided; affected units may require repair or replacement as per the manufacturer.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1212-2024 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1212-2024 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.