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Open, Classified

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.

FDA Recall Z-2025-2023 · Posted 2023-06-29

Recalling FirmDRE Medical Group Inc
Recall StatusOpen, Classified
Product CodeMNT
Date Initiated2023-05-15
Product Quantity22 units

Reason for Recall

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.

Firm Action

Avante Health issued URGENT: Medical Device Recall Philips Respironics V60 Ventilators Letter on 5/12/23 via email. Letter states reason for recall, health risk and action to take: " Immediately discontinue use. " Contact Avante Health Solutions for an RMA and shipping label to return the device. These devices must be returned to our facility for destruction. " Comparable replacement devices will be available for immediate shipment or " Credits can be issued. " Please email [email protected] to acknowledge receipt of this urgent recall " Attachments of Acknowledgement and Receipt Forms . Contact Information: Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. (800) 462-8195 or (502) 244-4444 [email protected]

Root Cause

No Marketing Application

Distribution Pattern

US: CA, FL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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