Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Reported: May 11, 2022 Initiated: March 18, 2022 #Z-1034-2022
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
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 731 units
- Distribution
- Nationwide
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.. Recalled by Olympus Corporation of the Americas. Units affected: 731 units.
Why was this product recalled? ▼
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1034-2022.
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