Moderate riskFDA DeviceClass II
Pentax EG-3270UK ultrasound endoscope needs updated water instructions
Pentax of America is updating the instructions for use for its EG-3270UK ultrasound endoscopes and their water bottle assemblies. The new warnings say to make sure there is deaerated sterile water in the assembly before and during each procedure. No injuries have been reported, and the notice covers 65 units across all serial numbers.
From the FDA notice · Read the official notice ↗
What to do
- Review the updated instructions for use for the EG-3270UK and its water bottle assembly.
- Make sure the water bottle contains deaerated sterile water before and during each procedure.
- Contact Pentax of America with questions about your affected unit.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.
- Sold in
- Nationwide
- Made for
- Adults (18 years to 120 years)
This recall covers 5 products — see all of them.
Details
- Units affected
- 65 units
- Illnesses reported
- None reported
- Manufactured in
- 3 Paragon Dr, Montvale, New Jersey, United States
- Classification
- Class II
- Recall number
- Z-0309-2027
In the FDA's words
- Description
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. Model No. EG-3270UK; UDI-DI: 04961333237050, 04961333237067, 04961333226580, 04961333254187, 04961333233793; All Serial Numbers. Distribution: Worldwide - US Nationwide and International distribution - Pending. Affected quantity: 65 units
- Hazard
- Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.
5 products in this recall
The agency lists each product separately. Check every one you might have.
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.Z-0306-2027 · 84 units
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.Z-0307-2027 · 182 units
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.Z-0308-2027 · 737 units
- PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. (this page)Z-0309-2027 · 65 units
- PENTAX Medical Water bottle assembly. Model Number. OS-H5.Z-0310-2027 · 2,972 units