Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predeter
Summary
The FDA issued a Class II for Philips Respironics V60 Ventilator-Intended to mechanically control or assist pa by DRE Medical Group Inc. 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 .
Details
Source
Device Recall
External ID
Z-2025-2023
Action Date
2023-07-05
Status
Ongoing
Category
device
Product Description
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.
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
Quantity Affected: 22 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-15
Company
Louisville, KY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 367 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DRE Medical Group Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DRE Medical Group Inc have FDA actions?
This is the only FDA action we have on record for DRE Medical Group Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2025-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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