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# FDA Proposes 2nd Section 518(b) Order for Philips
- URL: https://www.fdaweb.com/fda-proposes-2nd-section-518-b-order-for-philips/
- Published: 2022-05-03T12:00:00.000Z
- Updated: 2026-09-14T17:43:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151733

FDA is proposing that a Section 518(b) order be issued to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after 11/2015.

In 6/2021, FDA [says](https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recalls-frequently-asked-questions?ref=fdaweb.com), Philips recalled certain ventilators, bi-level positive airway pressure, and continuous positive airway pressure machines due to potential health risks. The statement says the polyester-based polyutrethane foam used in the devices to lessen sound and vibration can break down. If this occurs, it says, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.

The agency statement says the proposed order is in addition to its 3/2022 Section 518(b) [order](https://www.fdaweb.com/philips-hit-with-rare-518-a-order-on-ventilators/) requiring the company to provide notification to customers of the recall and the health risks presented by the recalled devices. The agency says the first order was necessary due to “inadequate” company notification efforts.

Philips has an opportunity for an informal hearing before FDA determines whether to issue the new order for a company plan to repair, replace, or refund the units’ purchase price.