Philips Garbin Ventilator Foam May Separate, Blocking Air Intake
Silicone foam in some Philips Garbin Ventilators may separate and block the air inlet, reducing therapy volume and causing alarms. Nine units are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a severity score of at least 4. Malfunction of a respiratory device with blocked air inlet reduces therapy delivery, posing serious risk to patients dependent on ventilator support.
Plain-English summary
Philips Respironics is recalling the Philips Garbin Ventilator, Model Number 1058180B, affecting 9 specific units. The replacement silicone sound abatement foam installed in these devices may separate from its plastic backing.
If the foam separates, it could block the air inlet, potentially reducing the volume or pressure of therapy delivered to the patient. The device may also trigger an alarm if this separation occurs.
The affected units have been distributed in the United States and internationally to Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America. Patients and healthcare providers using these devices should contact Philips Respironics for guidance on remediation options.
The recalled product
- Product
- Philips Garbin Ventilator, Model Number 1058180B
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00606959429338
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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