Ultrasonic Gastrovideoscope Model TGF-UC180J Recalled for Inadequate Channel Drying
Aizu Olympus is recalling ultrasonic gastrovideoscopes due to an unvalidated channel drying process that left some scopes with water in the channels after repair. Water remaining in the device poses a risk of contamination and infection.
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: This is an FDA Class II recall for a medical device with a theoretical infection risk due to inadequate drying process validation. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Aizu Olympus Co., Ltd. is recalling the ultrasonic gastrovideoscope Model TGF-UC180J. The recall was initiated because the channel air drying process used after repairs was not validated. A small percentage of devices returned to customers after repair contained water in the channels.
Water remaining in the endoscope channels has the potential for contamination that could lead to infection. This device is used for real-time ultrasound imaging, ultrasound-guided needle aspiration, and other endoscopic procedures in the upper gastrointestinal tract and surrounding organs.
Five units of this model were distributed nationwide in the United States. Customers who have received this device should contact Aizu Olympus Co., Ltd. for further information regarding this recall.
The recalled product
- Product
- Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- Hazard
- water-contamination
- infection-risk
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)
- Model Number (UDI-DI): TGF-UC180J (04953170328480).
Distribution
Distributed nationwide across the United States.
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