Z-1034-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- March 18, 2022
- Termination Date
- N/A
- 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