Olympus Video Gastroscope Recall Due to Internal Coil Detachment Risk
Integrated Medical Systems Inc is recalling four Olympus GIF-XQ140 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 involves a medical device with a functional defect that could compromise the intended operation of the instrument during a procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where specific injury or illness has not yet been reported.
Plain-English summary
Integrated Medical Systems Inc is recalling four Olympus Model No. GIF-XQ140 flexible video gastroscopes. The recall is due to a defect where excessive pressure applied to the distal end of the endoscope can cause the internal coil pipe assembly to become detached. When this occurs, the angulation mechanism may not operate as intended.
The affected instruments have serial numbers 2600297, 2601232, 2600397, and 2013906. These devices were distributed nationwide in the United States and in Australia.
Healthcare providers should stop using the affected devices and contact Integrated Medical Systems Inc for further instructions on the recall.
The recalled product
- Product
- Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
- Manufacturer
- Integrated Medical Systems Inc
- Category
- Medical Device — Endoscope
- Affected units
- 4
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 (4)
- Serial Numbers: 2600297
- 2601232
- 2600397
- 2013906
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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