Olympus Video Duodenoscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling 16 Olympus TJF-160F video duodenoscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
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 involves a medical device with a mechanical defect that could prevent intended operation, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Integrated Medical Systems Inc is recalling 16 units of the Olympus Model No. TJF-160F flexible scope, large diameter, video duodenoscope. The recall involves specific serial numbers listed in the agency documentation.
The recall is being issued because if excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end can become detached. This failure may result in the angulation mechanism not operating as intended.
The affected instruments were distributed nationwide in the United States and in Australia. Healthcare providers and facilities should identify these specific serial numbers and stop using the affected devices.
The recalled product
- Product
- Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 16
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 (16)
- Serial Numbers: 2201503
- 2000062
- 2000105
- 2100621
- 2301997
- 2100999
- 2201555
- 2302025
- 2000061
- 2201491
- 2000039
- 2100930
- 2402518
- 2302084
- 2100852
- 2101121
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Integrated Medical Systems Inc 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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