Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B,…
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in…
Read the official notice →- Date
- 2023-06-14
- Country
- United States
- Brand
- Philips Respironics
- Product
- Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B,…
- Classification
- Class I
- Units
- US Nationwide. Global Distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Philips Respironics recalls
- 2023-10-04
USPhilips Respironics, Inc. recalls Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276…
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
FDA · DevicePhilips Respironics, Inc.US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.Official notice →- 2023-07-12
- US
Philips Respironics, Inc. recalls Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
- 2023-06-14
- US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric…
- 2023-04-12
- US
Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F, UFRX500S14.…
A limited number of remediated Philips DreamStation units may experience communication issues when connecting to the cloud-based care management application. Should this be the case, this may affect the ability to…
- US
Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B,…
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including Puerto Rico, and countries of…Official notice → - 2023-01-18
- US
Philips Respironics, Inc. recalls Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B,…
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially…
FDA · DevicePhilips Respironics, Inc.US Nationwide and Global Distribution to countries of: Australia, Brazil,…Official notice →
Other drugs & medical recalls in the United States
- 2023-06-14
- US
Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
FDA · DeviceElekta, Inc.US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI,…Official notice → - US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain…
FDA · DeviceMedtronic Navigation, Inc.US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA,…Official notice → - US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, Model Number DS2000X11B
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric…
- US
BearCare, Inc. recalls Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency…
There have been reports of skin burns to children wearing the device.
- US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice → - US