Olympus recalls GF-UM160 ultrasound endoscopes due to updated cleaning instructions potentially increasing infection risk during patient procedures.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Olympus is recalling its GF-UM160 ultrasound endoscopes because a recent update to their cleaning instructions might increase the risk of patient infections. This recall affects medical devices used for diagnostic imaging and fluid analysis.
The device's cleaning instructions were updated to include a new inspection step that could, if not followed correctly, lead to inadequate disinfection. This might increase the chance of patient infections during medical procedures.
Healthcare professionals using Olympus GF-UM160 ultrasound endoscopes for medical procedures are most at risk. Patients receiving these procedures may also be affected if proper infection control isn't maintained.
Check for the model number GF-UM160 on the device or its packaging. This ultrasound endoscope is used for diagnostic imaging and fluid analysis of the human body.
Check the updated Instructions For Use (IFU) for proper cleaning steps to reduce infection risk.
The device is safe if cleaned according to the updated Instructions For Use (IFU) to reduce infection risk.
Look for the model number GF-UM160 on the device or its packaging.
Review the updated cleaning instructions to ensure proper disinfection and reduce infection risk.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0504-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0504-2021 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.
