medical Class I Updated 2024-11-20

Philips Respironics, Inc. recalls Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110

Recalled Product

Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number (UDI-DI Number): AU2110X15B (606959051980); BL2110X15B (606959055520); BR2110X18B (606959055476); CA2110X12B (606959052307); DE2110X13B (606959054110); DS2110X11B (606959051942); EE2110X15B (606959055544); ES2110X15B (606959054080); EU2110X15B (606959054981); EU2110X19 (606959055537); FP2110X10 (606959062092); FR2110X14B (606959055506); GB2110X15B (606959054127); IA2110X15B (606959055490); IN2110X15B (606959051959); IT2110X21B (606959055421); JP2110X16B (606959051973); KR2110X15B (606959055483); LA2110X15B (606959055452); ND2110X15B (606959055513); PP2110X10 (606959054035); RBRBR2110X18B (606959055476); RDS2110X11B (606959060517); TR2110X15B (606959055551); UDS2110X11B (606959060500). All Serial Numbers.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.