Olympus GIF-160 Video Gastroscope Recalled for Internal Coil Detachment
Integrated Medical Systems Inc is recalling 111 Olympus GIF-160 video gastroscopes because excessive pressure may cause the internal coil pipe assembly 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 is classified as FDA Class II, and the hazard involves a mechanical failure that could compromise the intended operation of a medical device, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc is recalling 111 Olympus Model No. GIF-160 flexible video gastroscopes. The recall was initiated 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. When this occurs, the angulation of the endoscope may not operate as intended.
The affected instruments were distributed nationwide in the United States and in Australia. The recall covers specific serial numbers listed in the official agency documentation.
Healthcare providers and consumers should stop using the affected instruments and contact Integrated Medical Systems Inc for further instructions on repair or replacement.
The recalled product
- Product
- Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 111
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 (20)
- Serial Numbers: 2203925
- 2001221
- 2205721
- 2102757
- 2102758
- 2000420
- 2419219
- 2001053
- 2001248
- 2001285
- 2103701
- 2307844
- 2408213
- 2419900
- 2419587
- 2419391
- 2307188
- 2408135
- 2408138
- 2205035
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.
See all 22 products in this recall →Related recalls
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