Garbin Evo. Model Number: LD2110X23B. 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.
This recall is currently active, issued November 13, 2024. It was issued by Philips Respironics, Inc..
- Company
- Philips Respironics, Inc.
- Recall Initiated
- October 7, 2024
- Posted
- November 13, 2024
- Recall Number
- Z-0295-2025
- Quantity
- 1,322 units
- Firm Location
- Murrysville, PA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model No. LD2110X23B; UDI-DI: 606959057432; All Serial Numbers.
Root Cause
Device Design
Action Taken
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).