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.
Read the official notice →- Date
- 2023-10-04
- Country
- United States
- Brand
- Philips Respironics
- Product
- Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
- Classification
- Class I
- Units
- US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 → - 2024-01-10
- US
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…
FDA · DevicePhilips Respironics, Inc.Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL,…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…
- US
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…
Other drugs & medical recalls in the United States
- 2023-10-04
- US
Inmar Supply Chain Solutions, LLC recalls Various Medical Products stored on pallets, including but not limited to bandages, tampons, condoms, blood glucose monitors,…
Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product labeling.
- US
Exocad GmbH recalls exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the…
A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is…
FDA · DeviceExocad GmbHWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Covidien LP recalls Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body.
FDA · DeviceCovidien LPWorldwide distribution - US Nationwide and the countries of Austria, Belgium,…Official notice → - US
WOM World Of Medicine AG recalls Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to…
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached…
FDA · DeviceWOM World Of Medicine AGNationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany,…Official notice → - US
Ambu Inc. recalls Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices,…
Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames
- US
RB Health (US) LLC recalls Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per…
Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.