Philips Respironics, Inc. recalls Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B…
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10…
Read the official notice →- Date
- 2024-01-10
- Country
- United States
- Brand
- Philips Respironics
- Product
- Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B DS2110X11B EE2100X15B…
- Classification
- Class II
- Units
- Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-05-29
USPhilips Respironics, Inc. recalls OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127…
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or…
FDA · DevicePhilips Respironics, Inc.US Nationwide distribution and OUS International distribution to Canada.Official notice →- US
Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator, Part Number 1111178
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium,…Official notice → - 2024-04-24
- US
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
FDA · DevicePhilips Respironics, Inc.Domestic: Nationwide Distribution; Foreign: AE, AR, AT, AU, BD, BE, BG, BO,…Official notice → - 2023-10-04
- US
Philips 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…
Other drugs & medical recalls in the United States
- 2024-01-17
- US
InvaGen Pharmaceuticals, Inc. recalls Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc.,…
Defective Container: powder may leak out of the pouch
- US
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090,…
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- 2024-01-10
- US
Zimmer Biomet Spine Inc. recalls Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw…
FDA · DeviceZimmer Biomet Spine Inc.US Nationwide distribution in the states of MN, NE.Official notice → - US
Abiomed, Inc. recalls Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella…
The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature;…
- US
Natus Medical Incorporated recalls EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.
FDA · DeviceNatus Medical IncorporatedUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Beaver Visitec International, Inc. recalls Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.