№ files_lp_4_process_3_120638
Mandatory field safety notice informing healthcare providers and users of Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 ventilators about a critical software update and User Manual addendum resolving previously reported safety and additional non-safety issues.
Year: 2024
Organization: Philips Respironics
Document type: Field Safety Notice
Products affected: Trilogy Evo, Trilogy Evo O2, Trilogy EV300 ventilators
Software version: 1.06.10.00
Purpose: Notification of mandatory software update and User Manual addendum
Issues addressed: Safety-related and non-safety-related software and labeling issues
Target audience: Healthcare providers, distributors, patients, and users of affected devices
Original communication dates: April 2023, November 2023, February 2024
Required action: Immediate software update and distribution of updated information
Follow-up procedure: Completion and return of response form within 30 days
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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