New FDA Guidance on MDR Reporting Of Y2K Events
Carpal Tunnel Release System Handpiece Recalled for Sticking Trigger Linkage Pins
Incorrect Calibration Level Leads To Recall of Blood Gas Analyzer System
Aneurysm Clips Recalled; Blades May Not Be Properly Aligned
Handswitching Suction Coagulator Remains Activated After Button Released; Devices Recalled
Needle Electrode Recalled Because Product Has Potential to Abrade Tissue
PTCA Balloon Catheters Recalled After Wrong Sterilization Process Used
Mislabeling Leads to Recall of Implants, Cover Screws
Corrective Action Plan for Ophthalmology Laser System Approved by FDA
Excimer Laser Subject of Field Correction; Gap Allows Direct Line-of-Sight Access to Beam
Field Correction Issued on Ruby Laser System; Operator's Manual Lacks Calibration Procedures
Software Error Leads to Recall of Steam Sterilizer
Tissue Suture Anchors Recalled For Sterility Problems
Reported Circuit Board Failures In Portable Oxygen Generator Lead to Field Correction
Patient Scales Recalled; Screw Securing Scale May Become Disengaged, Causing Patient Falls
Mislabeled Acid Concentrate for Bicarbonate Dialysate Recalled
Electromagnetic Compatibility Conferences
Joint Commission and American College of Surgeons' Commission On Cancer Announce Agreement
Joint Commission Lobbies for Mandatory Reporting of Restraint Deaths in Psychiatric Facilities