Recall Z-2025-2023 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
DRE Medical Group Inc
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.
| Date | Jun 29, 2023 (initiated May 15, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | No Marketing Application |
| 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 quality.management@avantehs.com to acknowledge receipt of this urgent recall " Attachments of Acknowledgement and Recei |
| Quantity | 22 units |
| Distribution | US: CA, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.