Philips : Respironics field action - Progress update - 30 January, 2023

Progress update

Philips Respironics field action

January 30, 2023

The Respironics recall remains highest priority

2022	2023			2023-2025
~90% production and 80%		Finalize recall and testing	Manage impact of proposed
shipment of recall units					Consent Decree
Encouraging test results for DS1		Manage litigation,	Manage litigation,
platform (within safety norms)		DoJ investigation	DoJ investigation

483 remediation in progress	483 remediation and clarity on	Gradually restore position
	proposed Consent Decree

Taking the learnings of Respironics recall

to raise Patient Safety and Quality to the highest standards across Philips

2	© Koninklijke Philips N.V.

Extensive patient, clinician and regulator engagement

• Driving patient engagement and registrations with dedicated registration system and infrastructure
• • Continued patient outreach through mailing, call center, websites and direct contact with interest groups
  • Comprehensive DME outreach
  • Met the requirements in FDA's 518(a) order and continue to report progress

• Ongoing engagement with regulators to optimize the recall efforts

• Sharing progress on testing program to ensure patients and physicians fully informed

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~90% production and 80% shipment of recall units in 2022

The task at hand

• Around 5.5M devices expected to be repaired or replaced
• Equivalent to over 5x previous annual production volume
• >1 thousand new product configurations released globally
• Partnering with DME's for patient delivery

Progress to date

• Quadrupled production capacity compared to pre-recall
• >1,000 people cross functional team engaged
• Dependency on supply of materials and global logistics capacity
• ~90% production and 80% shipment of recall units in 2022

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Testing and literature review

© Koninklijke Philips N.V.