Z-1034-2022 Class II Ongoing
FDA device recall Z-1034-2022 was initiated by Olympus Corporation Of The Americas on Mar 18, 2022 and is designated Class II. Reason for recall: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients The recall status is ongoing. Affected quantity: 731 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- Mar 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 731 units
Product Description
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Reason for Recall
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Distribution Pattern
Nationwide
Code Information
All serial numbers. GTIN: 04953170356322
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1034-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026