Class 1 Device Recall Garbin Evo

• Date Initiated by Firm: October 07, 2024
• Date Posted: November 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0296-2025
• Recall Event ID: 95486
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
• Code Information: Model No. SP2100X26B; UDI-DI: 606959057456; All Serial Numbers.
• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• For Additional Information Contact: Philips Customer Service; 1-800-345-6443
• Manufacturer Reason for Recall: Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
• FDA Determined Cause: Device Design
• Action: An URGENT Medical Device Correction notification was mailed to consignees on 10/07/2024. The notification provides instructions to users to prevent risks for patients when using in-line nebulizers and a set FiO2. Consignees are to distribute the provided notification to all members of their organization responsible for setting up and supervising patients who use these devices. Additionally, if affected devices were further distributed the notification needs to be provided to them. Philips Respironics is currently investigating the issue and plans to follow-up communications to customers to provide additional guidance and solutions at a later date. Consignees with any questions can contact their local Philips Respironics Customers Service at: For DME and Homecare Customers: 1-800-345-6443, option 4, option 5 For Hospital Customers: 1-800-722-9377, option 2. On 12/27/2024, Philips Respironics sent an updated letter to consignees. It included additional guidance to customers. Dependent upon the scenarios described, customers will be instructed to either contact one of the options provided in the Urgent Medical Device Correction letter for servicing of their device to replace the flow sensor or continue use of the device in accordance with the guidance provided in the Urgent Medical Device Correction letter. Execution of flow sensor replacement will take place through a Field Change Order (FCO).
• Quantity in Commerce: 1,244 units
• Distribution: Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.