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
    • 100043954
    • 100050078
    • 100052760
    • 100052848
    • 100054619
    • 100054626
    • 100055277
    • 100055557
    • 100058549
    • 100058566
    • 100058837
    • 100058995
    • 100060228
    • 100065373
    • 100069520
    • 100070487
    • 100071122
    • 100072691
    • 100078379
    • 100080232
    • 100080844
    • 201003462
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.