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Baxter Issues Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ Infusion Pumps with Specific Software Versions

Murilo Freitas - 04:00, 30 de julio de 2023292
Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for Spectrum V8 and Spectrum IQ infusion pumps in the U.S. and Puerto Rico that have been upgraded to software versions v8.01.01 and v9.02.01. The Correction is due to an increase in reported false upstream o

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-spectrum-v8-and-spectrum-iq-infusion-pumps-specific

 
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Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point

Murilo Freitas - 04:00, 30 de julio de 2023265
Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two (2) lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the patient (consumer/user) level due to out of specification (OOS) test results at t

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntary-nationwide-recall-2-lots-tydemytm-drospirenone-ethinyl

 
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GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate Readings

Murilo Freitas - 04:00, 27 de julio de 2023596
TruSignal sensors monitor SpO2 and pulse rate. Sensor issues may impact patient care delivery including defibrillation without care providers’ knowledge.

http://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-trusignal-spo2-sensors-issues-may-reduce-defibrillation-energy-expose-patients

 
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Abiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) Stent

Murilo Freitas - 04:00, 26 de julio de 2023686
The motor housing of Impella blood pumps may come into contact with TAVR distal stents, causing damage to the motor blades and impacting pump flow.

http://www.fda.gov/medical-devices/medical-device-recalls/abiomed-recalls-all-impella-left-sided-blood-pumps-risk-motor-damage-after-contact-transcatheter

 
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Intended Use of Imaging Software for Intracranial Large Vessel Occlusion – Letter to Health Care Providers

Murilo Freitas - 04:00, 25 de julio de 2023422
The U.S. Food and Drug Administration (FDA) wants to increase awareness about the intended use of imaging software for intracranial large vessel occlusion or LVO.

http://www.fda.gov/medical-devices/letters-health-care-providers/intended-use-imaging-software-intracranial-large-vessel-occlusion-letter-health-care-providers

 
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