FDA Device recall Z-0342-2024
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon)
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon) by Aizu Olympus, citing channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the end….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0342-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-25 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aizu Olympus |
| Distribution | US |
Product
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Reason
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Identifiers
| code_info | Model Number (UDI-DI): PCF-S (04953170339912). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0342-2024%22
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