Olympus Video Gastroscope Recalled Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc. is recalling nine Olympus GIF-Q140 video gastroscopes because excessive pressure can cause the internal coil pipe to detach, preventing proper angulation.
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 involves a mechanical defect in a medical device that could prevent the instrument from operating as intended during a procedure. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc. is recalling nine Olympus Model No. GIF-Q140 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 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 specific serial numbers for the nine recalled units are 2813102, 2914792, 2711389, 2711291, 2812266, 2812356, 2802476, 2600371, 2914632, and 2914333.
Healthcare facilities and users should check their inventory for these specific serial numbers. If the instruments are found, they should be removed from service and returned to Integrated Medical Systems Inc. for evaluation or repair.
The recalled product
- Product
- Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 9
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 (10)
- Serial Numbers: 2813102
- 2914792
- 2711389
- 2711291
- 2812266
- 2812356
- 2802476
- 2600371
- 2914632
- 2914333
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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