Device product
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Z-1034-2022
Product summary
- Event
- Event 89921
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 731 units
- Official record key
device-enforcement:Z-1034-2022
Official wording
Reason: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Code information: All serial numbers. GTIN: 04953170356322
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients