Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect
Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.
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 minimum severity rating of 4 (Severe). Although no illnesses or injuries have been reported, the manufacturing defect affects critical respiratory support equipment prescribed for sleep apnea and respiratory insufficiency.
Plain-English summary
Philips Respironics, Inc. is recalling OmniLab Advanced + ventilators with heated tube humidifiers due to a manufacturing defect. The motor assemblies contain nonconforming plastic that releases volatile organic compounds (VOCs) during operation, posing a potential respiratory health risk to users.
The recall affects 8 units distributed throughout the United States and internationally. Affected devices are identified by model numbers 1111124 and R1111124 along with specific serial numbers provided in the FDA recall documentation.
Patients currently using an affected ventilator should contact Philips Respironics for return, repair, or replacement instructions. Do not discontinue use without consulting your healthcare provider, as these devices treat obstructive sleep apnea and respiratory insufficiency. Report any health concerns to your physician.
The recalled product
- Product
- Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Manufacturer
- Philips Respironics, Inc.
- Affected units
- 8
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 (12)
- UDI-DI: 606959067837
- 606959068001
- Model No.: 1111124
- R1111124
- Serial No. L29084645477C
- L303986771E8D
- L303987043BC2
- L3039871356A5
- L30398768A57E
- L303987892EE7
- L30398795FD53
- L30398849CD80
Distribution
Part of a larger recall action
This product is one of 6 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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