Company: Philips Medical SystemsDate of Enforcement Report: 5/25/05 Class: II PRODUCT Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05. REASON The device may disarm and not deliver shock when performing a Synchronized Cardioversion. CODE Software Versions A.03.00 or lower and B.04.00 and lower. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter...Read More

Recipient: BioImageneProduct: PATHIAM software Date: 5/25/05 According to your website, PATHIAM is “a hardware-independent, Web-enabled software allowing pathologists to view and analyze immunohistochemically-stained (IHC-stained) slides from any computer via the Internet.” PATHIAM is a device as that term is defined in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S .C. 321(h))...Read More