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
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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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