The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1658-2022·Announced 2022-09-14

Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing

Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.

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 is an FDA Class I recall. Per the severity rubric, FDA Class I recalls cannot be scored below 4 (Severe). While no illnesses or deaths have been reported, the product is a medical device for respiratory support, and the nonconforming plastic material presents a potential health risk through VOC off-gassing.

Plain-English summary

Philips Respironics, Inc. is recalling Philips OmniLab Advanced+ Intl (Flow Gen) noninvasive ventilation devices used to provide breathing support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.

The recall affects devices with motor assemblies manufactured from nonconforming plastic that contributes to the release of volatile organic compounds (VOCs). VOCs are chemical emissions that may present a health risk to device users.

Approximately 37 units have been identified as affected. The devices were distributed across multiple US states and internationally, including Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, and the UK.

Owners of affected devices should contact Philips Respironics, Inc. for information regarding device replacement or repair options.

The recalled product

Product
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory Support / Sleep Apnea Device
Hazard

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: 606959029415
  • 606959028791
  • Model No.: 1109582
  • 1109585
  • Serial No. L28664715858F
  • L286647269D7C
  • L286647278CF5
  • L28870204F469
  • L28870206D77B
  • L28870207C6F2
  • L288702092F8C
  • L28870210AB95
  • L28870211BA1C
  • L288702128887
  • L28870214EDB1
  • L28870215FC38
  • L28870216CEA3
  • L28870217DF2A
  • L290843744520
  • L2908437554A9

Distribution

Distributed in 42 states:

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 →

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