AAMI Standards Conference Software Session 2005 including 4 FDA presentations The following are all included in the pdf at the following link: AAMI Standards Conference Software Session 2005 Review of Software in Premarket Submissions (new guidance for CDRH and CBER) – David S. Buckles FDA CDRH ODE Cybersecurity for Networked Medical Device Containing (OTS) Off-the-Shelf Software...Read More

Company: Philips Medical Systems Sales and Service Region No. Americ.Date of Enforcement Report: 3/30/05 Class: II PRODUCT Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05. REASON Loss of image data from image repository and archive requiring patients to undergo repeat imaging. CODE Xcelera Software version R1.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems...Read More

Company: Heartsine Technologies, IncDate of Enforcement Report: 3/30/05 Class: I PRODUCT Heartsine Samaritan AED Defibrillators — Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05. REASON The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow...Read More