Reported Jul 5, 2023 · Ongoing
Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a…
DRE Medical Group Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DRE Medical Group Inc · 2601 Stanley Gault Pkwy Ste 101 · Louisville, KY · 40223
Is this the product you have?
- Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas
- Model NumberR1053618 and R1076709. These are retrofitted device
- Lot codes and dates
- USI-DI00884838009868
- Serial NumbersSerial Number
100043954100050078100052760100052848100054619100054626100055277100055557100058549100058566100058837100058995100060228100065373100069520100070487100071122100072691100078379100080232100080844201003462
- Amount recalled
- 22 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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