Olympus GIF-140 Video Gastroscope Recalled for Detached Coil Pipe Assembly
Integrated Medical Systems Inc is recalling 12 Olympus GIF-140 video gastroscopes because the internal coil pipe assembly may detach under pressure, causing angulation failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device's intended function during a medical procedure, representing a risk of harm without reported injuries.
Plain-English summary
Integrated Medical Systems Inc is recalling 12 Olympus Model No. GIF-140 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. 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. The specific serial numbers for the recalled units are 2801185, 2801376, 2700216, 2903833, 2903851, 2700830, 2801154, 2700481, 2700049, 2025259, 2802540, and 2700325.
Healthcare providers and facilities should check their inventory for these specific serial numbers. If a unit is found, it should be removed from service and returned to Integrated Medical Systems Inc according to the recall instructions.
The recalled product
- Product
- Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 12
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 (12)
- Serial Numbers: 2801185
- 2801376
- 2700216
- 2903833
- 2903851
- 2700830
- 2801154
- 2700481
- 2700049
- 2025259
- 2802540
- 2700325
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
Same manufacturer · Integrated Medical Systems Inc
See all →- HighOlympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
- HighOlympus CF-Q160L Video Colonoscopes Recalled for Detached Internal Coil Pipe Assembly
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- HighOlympus Video Gastroscope Recall Due to Detached Internal Coil Assembly
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- HighOlympus Video Colonoscope Recall Due to Internal Coil Detachment Risk
FDA (Devices) · 2016-03-02
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