Olympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
Integrated Medical Systems Inc is recalling 180 Olympus GIF-H180J video gastroscopes because excessive pressure can 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. The hazard involves a mechanical failure that prevents the device from operating as intended, which poses a risk of harm during a medical procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integrated Medical Systems Inc is recalling 180 units of the Olympus Model No. GIF-H180J flexible scope, large diameter, video gastroscope. 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 mechanism 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 FDA record Z-0893-2016.
Healthcare providers and consumers should stop using the affected devices immediately. Users should contact Integrated Medical Systems Inc for instructions on how to return the instruments for repair or replacement.
The recalled product
- Product
- Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 180
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: 2102433
- 2102439
- 2102434
- 2002026
- 2002023
- 2000101
- 2000567
- 2001703
- 2317892
- 2001252
- 2103738
- 2206336
- 2001183
- 2317780
- 2317782
- 2001658
- 2002113
- 2002108
- 2001058
- 2205716
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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