Olympus Ultrasound Endoscope Recall for Infection Risk
Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning instructions.
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 Olympus Ultrasound Endoscopes. The recall involves 299 units of the GF-UM160 model, as well as other models including the GF-UC140P-AL5, GF-UCT150-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UC160P-OL5, GF-UCT160-OL5, and GF-UE160-AL5. These devices are used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
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.
The devices were distributed worldwide and nationwide in the United States. Affected users should refer to the updated Instructions For Use to ensure proper cleaning and disinfection procedures are followed to mitigate infection risks.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 299
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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