Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing
Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.
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: This device recall is classified as FDA Class I, a designation reserved for serious hazards. Per the severity rubric, FDA Class I status establishes a minimum rating of Severe (score 4).
Plain-English summary
Philips Respironics, Inc. is recalling 85 units of the Philips OmniLab Advanced+, a medical device designed to provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.
The recalled devices contain motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of volatile organic compounds (VOCs).
The recall affects devices distributed throughout the United States and internationally to multiple countries including Australia, Canada, China, Germany, Japan, and the United Kingdom. Specific model and serial numbers affected are detailed in the FDA recall notice.
The recalled product
- Product
- Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- Affected units
- 85
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 (20)
- UDI-DI: 606959028791
- Model No.: 1109581
- Serial No. L28664716B714
- L28664717A69D
- L286647185E6A
- L286647194FE3
- L28664720F84A
- L28664721E9C3
- L28664722DB58
- L28664723CAD1
- L28664724BE6E
- L28870984130F
- L288709850286
- L28870986301D
- L288709872194
- L28870988D963
- L28870989C8EA
- L288709904CF3
- L288709915D7A
- L288709926FE1
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.
See all 6 products in this recall →Related recalls
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Same hazard · voc off gassing
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