Tecnología Médica

Tecnología Médica

Autocat 2 Systems
25/11/2022 - Teleflex has initiated a voluntary field safety corrective action due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices...
Vivid Ultrasound Systems
25/11/2022 - Potential for smoke or fire in certain legacy vivid ultrasound systems with batteries not replaced as recommended. Recall start date: November 10, 2022
Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment
25/11/2022 - The WatchCare IMS includes hospital beds and disposable incontinence pads. Radiofrequency emissions from the system may interfere with other medical devices.
Ranger Blood/Fluid Warming Systems
22/11/2022 - This recall has been initiated due to the risk of blood or fluid leak while priming the sets and/or during fluid administration. 3M has received complaints regarding leaks associated with the...
Trackmaster Treadmills
22/11/2022 - Full Vision is conducting a corrective action related to the magnetic safety tether. When the magnetic safety tether is pulled, the treadmill may fail to stop resulting in a potential injury. Recall...
Permanent Life Support Set
22/11/2022 - PLS set itself is delivered sterile and compliant, this issue relates to maintaining sterility after opening the pls set and removal of components (5) and (14) from the pls set tray for use in a...
Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller
16/11/2022 - Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), today announced a Medical Device Correction for the Omnipod® 5 Automated Insulin Delivery System because of an issue with the...
Custom-Pak™ Ophthalmic Surgery Procedure Pack
11/11/2022 - Alcon received notice of a product recall from their vendor, 3M, regarding their 3M Steri-drape™ surgical drapes, which are included in specific lots of Alcon Custom Pak®. The reason of this...
2.5mm Lifeport Adapters and Patient Circuit Kits
11/11/2022 - Bunnell has received reports of 2.5 mm Lifeport adapters with deformations at the patient end tip. These deformations may result in a narrowing of the effective internal diameter of the Lifeport. An...
Liberator Stationary Liquid Oxygen Device
10/11/2022 - There were inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle. This can lead to premature inner vessel failure. The failure mode would be potential loss of vacuum,...
Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter
07/11/2022 - Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of affected lots of the below-referenced...
Da Vinci Xi/X Sureform 45/60 Stapler
03/11/2022 - Intuitive has observed an increase in complaints regarding engagement failures associated with Da Vinci x/xi Sureform 45 and 60 stapler instruments. This is related to specific lots and as a...
Sonicaid Freedom Wireless Fetal Monitoring System
31/10/2022 - Huntleigh has received a report from a user regarding the potential for inappropriate clinical diagnosis and action due to the incorrect setup of the RF channels. In the particular case in question,...
Omnipod Dash System
31/10/2022 - Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in...
Orise Proknife Procedure and Gel Syringe Kits
27/10/2022 - Boston Scientific recently became aware of events associated with foreign body reaction which presented as mass formations from remnant Orise gel post procedure, prompting unnecessary surgical...
Novum Iq Large Volume Pump (LVP)
27/10/2022 - Baxter Corporation is issuing an urgent medical device correction related to two different software issues that occur during use. The first issue observed is due to incorrect reported delivered...
Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication
26/10/2022 - Do not to use the recalled Mighty Bliss electric heating pads due to the risks of injury, including electric shocks, skin burns, rashes or irritation.
La AEMPS informa del cese de utilización temporal de determinadas sillas eléctricas plegables QUICKIE Q50R
26/10/2022 - La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha tenido conocimiento, a través del fabricante Jiangsu Intco Medical Products Co., LTD, del cese de...
Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns
25/10/2022 - Boston, MA, October 18, 2022 / PRNewswire / – Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product...
Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System
25/10/2022 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF)...
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
20/10/2022 - Certain Philips Respironics masks for BiPAP and CPAP machines are recalled due to a risk that their magnetic clips may interact with other medical devices.