Z-2025-2023Class II

Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering...

Name: Z-2025-2023 Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering...
Creator: DRE Medical Group Inc
Published: 2023-05-15
License: https://open.fda.gov/license/

DRE Med / initiated 2023-05-15 / Open, Classified

FDA source

DRE Medical Group Inc began a recall of Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the... on 2023-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2025-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-06-29
Recalling firm: DRE Med
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.
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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.
FDA 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 [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]
Quantity in commerce: 22 units
Distribution: US: CA, FL
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2025-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2025-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-28

Product code MNT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)