Third and Last Strike Given by FDA to OEMs for Y2k Data
Potential for Airflow Obstruction in Breathing Circuit Adapter
Bad Chip Causes System Reset in Ventilator
Mobile X-Ray Stand Lock Nut Could Loosen
X-Ray Generator Noncompliant in Manual Spot-Film Mode
Ultrasound System Overestimates Peak Blood Velocity
Calibrator May Give False Reading
Pacemaker Programmer Software Causes Problem
Infant Monitors May Give False Alarm or Fail to Alarm
Error in Fiberscope Manual
FDA Causes Confusion Regarding MDR
Judge Rules FDA Off-Label Guidance Violates First Amendment