Date Initiated by Firm |
May 15, 2023 |
Date Posted |
June 29, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2025-2023 |
Recall Event ID |
92448 |
Product Classification |
Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
|
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. |
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
|
Recalling Firm/ Manufacturer |
DRE Medical Group Inc 2601 Stanley Gault Pkwy Ste 101 Louisville KY 40223
|
For Additional Information Contact |
SAME 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 |
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 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 Commerce |
22 units |
Distribution |
US: CA, FL
|
Total Product Life Cycle |
TPLC 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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