- Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Careby FDA on January 14, 2025 at 5:00 am
Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals.
- FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communicationby FDA on January 7, 2025 at 5:00 am
FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication
- Early Alert: Solution Set Issue from Baxter Healthcare Corporationby FDA on December 31, 2024 at 5:00 am
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
- 2024 Medical Device Recallsby FDA on December 31, 2024 at 5:00 am
The FDA posts information about certain medical device recalls and early alerts to help increase awareness of these issues.
- Early Alert: Fluid Delivery Set Issue from Medlineby FDA on December 30, 2024 at 5:00 am
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program