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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Respironics V60 Ventilator

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 Class 2 Device Recall Philips Respironics V60 Ventilatorsee related information
Date Initiated by FirmMay 15, 2023
Date PostedJune 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2025-2023
Recall Event ID 92448
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
ProductPhilips 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.
Code Information 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
FEI Number 1000122786
Recalling Firm/
Manufacturer		 DRE Medical Group Inc
2601 Stanley Gault Pkwy Ste 101
Louisville KY 40223
For Additional Information ContactSAME
502-244-4444
Manufacturer 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 Determined
Cause 2		No Marketing Application
ActionAvante 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
Quantity in Commerce22 units
DistributionUS: CA, FL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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