Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a risk of patient infection, which is a high-risk hazard, but the source text does not report any actual illnesses or injuries, fitting the criteria for a score of 3.
Plain-English summary
Olympus Corporation of the Americas is recalling specific models of ultrasound endoscopes, including the GF-UCT180, GF-UC140P-AL5, and others. The recall involves a total of 3,145 devices of the primary model and additional units of related models distributed worldwide and across the United States.
The recall was initiated because a new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU). This update is intended to reduce the risk of causing patient infections. The source text does not report any specific illnesses or injuries associated with the devices.
Healthcare facilities and users of these devices should review the updated Instructions For Use to ensure proper cleaning and disinfection procedures are followed. The recall covers all serial and lot numbers for the affected models.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancill
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 3,145
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial/Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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