Philips Respironics V60 Ventilator (DRE Medical) – Gas Fitting Risk (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
DRE Medical Group Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
USI-DI: 00884838009868 Serial Numbers: Serial Number 100043954 100050078 100052760 100052848 100054619 100054626 100055277 100055557 100058549 100058566 100058837 100058995 100060228 100065373 100069520 100070487 100071122 100072691 100078379 100080232 100080844 201003462
DRE Medical Group Inc is recalling Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by d due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 quality.management@avantehs.com 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 Quality.management@avantehs.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL
Page updated: Jan 10, 2026