CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Reported: December 6, 2023 Initiated: October 16, 2023 #Z-0415-2024
Product Description
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Reason for Recall
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Details
- Recalling Firm
- Aizu Olympus Co., Ltd.
- Units Affected
- 24 incorrectly repaired units
- Distribution
- Domestic distribution to FL, KY, MA, NJ, NY, and PA
- Location
- Aizuwakamatsu
Frequently Asked Questions
What product was recalled? ▼
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE. Recalled by Aizu Olympus Co., Ltd.. Units affected: 24 incorrectly repaired units.
Why was this product recalled? ▼
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 6, 2023. Severity: Moderate. Recall number: Z-0415-2024.
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