The Recall Desk
SevereFDA (Devices)·Z-0884-2023·Announced 2023-01-18

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Hazard
  • foam-separation
  • airway-obstruction
  • therapy-reduction

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.