FDAClass IJanuary 18, 2023

Philips Garbin Ventilator recall

Philips Garbin Ventilator, Model Number 1058180B

Why was Philips Garbin Ventilator recalled?

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 00606959429338; Serial Numbers: GV119100314 GV118011626 GV117030343 GV117020301 GV11910210D GV117060237 GV11807062D GV119070802 GV11605061E

Product
Philips Garbin Ventilator, Model Number 1058180B
Recalling firm
Philips Respironics, Inc.
Quantity
9
Distribution
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.
Recall date
January 18, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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