Philips North America Llc recalls Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May…
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- Philips
- Product
- Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Argentina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-10-09
USPhilips North America Llc recalls DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips…
If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a…
FDA · DevicePhilips North America LlcWorldwide - US Nationwide distribution in the states of CA, IL, ME, NC, NJ,…Official notice →- US
Philips North America recalls IntelliVue G7m Anesthesia Gas Module, Product Number 866173
The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a…
- 2024-10-02
- US
Philips North America recalls IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number…
During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding…
- 2024-08-14
- US
Philips North America Llc recalls IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health…
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the…
FDA · DevicePhilips North America LlcNationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China…Official notice → - 2024-07-10
- US
Philips North America Llc recalls Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Potential for inaccurate fetal heart rate measurements when monitoring multiples.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of AD, AE, AR, AT,…Official notice → - 2024-07-03
- US
Philips North America Llc recalls SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model…
Potential for coils to heat up and harm patients (burn).
FDA · DevicePhilips North America LlcWorldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-02
- US
Stryker Spine recalls AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion…
Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
FDA · DeviceStryker SpineWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Microcare Medical recalls Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution,…
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product…
FDA · DeviceMicrocare MedicalWorldwide - US Nationwide distribution in the states of MN, GA, PA, WA, CO,…Official notice → - US
Bard Peripheral Vascular Inc recalls BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System…
Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised.
FDA · DeviceBard Peripheral Vascular IncWorldwide - U.S. Nationwide distribution in the Puerto Rico and the countries…Official notice → - US
Argon Medical Devices, Inc recalls BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03,…
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to…
FDA · DeviceArgon Medical Devices, IncWorldwide - US Nationwide distribution including in the states of AZ, FL, OH,…Official notice → - US
Merit Medical Systems, Inc. recalls Custom Procedure Kit, REF: K12T-11077
7F sheath introducers labeled as 7.5F
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA,…Official notice → - US
CooperSurgical, Inc. recalls Stainless Steel Sims Uterine Sound, Part Number 64-601
During the manufacturing process the devices were laser-marked with the incorrect part number.
FDA · DeviceCooperSurgical, Inc.Worldwide distribution - US Nationwide and the countries of Armenia, Bahrain,…Official notice →