Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Olympus Medical Systems Corp. Colonoscope [Model Number: CF-H180AL, CF-HQ190I, CF-HQ190L, CF-Q180AL, PCF-H180AL, PCF-H190DL, PCF-H190L, PCF-H190TL, PCF-HQ190L, PCF-Q180AL] [HKMD number: 150080].
According to the FDA, specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads
For further information, please visit https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=93832
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 Mar 2024