Olympus GIF-Q180 Video Gastroscope Recall for Detached Coil Assembly
Integrated Medical Systems Inc. is recalling 185 Olympus GIF-Q180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
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 prevent the device from operating as intended during a procedure, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc. is recalling 185 units of the Olympus Model No. GIF-Q180 flexible scope, large diameter, video gastroscope. The recall covers instruments distributed in the United States and Australia.
The recall is being conducted 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.
Healthcare providers and facilities that have these specific instruments should check their serial numbers against the list provided in the official recall notice. If a device is affected, it should be removed from service and the recalling firm contacted for instructions on repair or replacement.
The recalled product
- Product
- Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 185
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: 2501321
- 2603572
- 2603751
- 2707414
- 2500011
- 2705546
- 2604232
- 2603079
- 2500780
- 2808458
- 2001720
- 2002054
- 2001724
- 2001723
- 2501905
- 2809593
- 2705417
- 2500916
- 2808421
- 2809413
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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