FDA-Device2023-07-05Class II
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
DRE Medical Group Inc
Hazard
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
Sold states
US: CA, FL
Affected count
22 units
Manufactured in
2601 Stanley Gault Pkwy Ste 101, N/A, Louisville, KY, United States
Products
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2025-2023Don't want to check this manually?
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