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.
This recall is currently active, issued June 29, 2023. It was issued by Dre Medical Group Inc.
- Company
- Dre Medical Group Inc
- Recall Initiated
- May 15, 2023
- Posted
- June 29, 2023
- Recall Number
- Z-2025-2023
- Quantity
- 22 units
- Firm Location
- Louisville, KY
- Official Source
- View on FDA website ↗
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.
Distribution
US: CA, FL
Lot / Code Info
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
Root Cause
No Marketing Application
Action Taken
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