Philips North America Llc recalls EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product…
A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
Read the official notice →- Date
- 2023-10-11
- Country
- United States
- Brand
- Philips
- Product
- EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of MA, MI. The country of…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 recalls
- 2023-11-17
SE
EURemote control (Philips) · 3986GR08
The solders in the product have an excessive concentration of lead (measured value up to 64 % by weight).Lead poses a risk to the environment. The product does not comply with the requirements of the Directive on the…
- 2023-11-15
USPhilips North America Llc recalls DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- US
Philips North America recalls Allura Xper IGTS Fixed Systems
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer…
FDA · DevicePhilips North AmericaUnited States Territories of Puerto Rico, Guam, and Virgin IslandsOfficial notice → - 2023-09-27
- US
Philips North America Llc recalls Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number:…
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central…
FDA · DevicePhilips North America LlcNationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark…Official notice → - 2023-08-16
- US
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and…
- US
Philips North America recalls Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
Other drugs & medical recalls in the United States
- 2023-10-11
- US
Thoratec Corp. recalls Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while…
FDA · DeviceThoratec Corp.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice → - US
Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide (there was government and military…Official notice → - US
GE Medical Systems China Co., Ltd. recalls F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)
There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the…
FDA · DeviceGE Medical Systems China Co., Ltd.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Apellis Pharmaceuticals, Inc. recalls Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body…
19-gauge x 1" inch filter needles showed appearances of a small fraction of non-preferred characteristics. A causal relationship has not been established between the structural variations in this 19-gauge filter needle…
- US
GE MEDICAL SYSTEMS, ISRAEL LTD. recalls Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed…
Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.
FDA · DeviceGE MEDICAL SYSTEMS, ISRAEL LTD.Worldwide distribution - US Nationwide distribution including government and…Official notice → - US
Covidien recalls Puritan Bennett Cuff Pressure Manager, REF: 180-03
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from…
FDA · DeviceCovidienUS: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El…Official notice →