Recall Z-2447-2023 ยท FEB Accessories, Cleaning, For Endoscope
Olympus Corporation of the Americas
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5
| Date | Aug 23, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure. |
| Root cause | Under Investigation by firm |
| Action | Olympus issued Urgent Medical Device Field Corrective Action letter on July 12,2023. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital and include a copy of this letter and addendum with any of these devices remaining in inventory. 2. Carefully read the content of this Medical Device Field Corrective Action as well as the attached Addendum for valve inspection instructions and updated MAJ-1444 reprocessing instructions: Disin |
| Quantity | 29590 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103264 | ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO Olympus Medical Systems Corporation, Feb 23, 2011 |