Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient Recalled by DRE Medical Group Inc Due to Devices were imported with Japanese Language and NIST...

Date: May 15, 2023
Company: DRE Medical Group Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DRE Medical Group Inc directly.

Affected 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.

Quantity: 22 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 2 states: CA, FL

Affected (2 states)Not affected

About DRE Medical Group Inc

DRE Medical Group Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report