Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT HeartStart XL Defibrillator Monitor. Model M4735A. Recall # Z-1226-03.M CODE Units with software versions A.02.00 or greater. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Andover, MA, by letter on September 2, 2003. Firm initiated recall is ongoing. REASON Instructions for use include additional information on configuration...Read More

Company: Philips Medical SystemsDate of Enforcement Report: 9/24/03 Class: II PRODUCT a) Gyroscan ACS-NT with software versions R6x, R7x, R8x. Recall # Z-1227-03; b) Gyroscan NT-Intera. Recall # Z-1228-03; c) Gyroscan Intera 1.0T & 1.5T. Recall # Z-1229-03. REASON Patient burns from cables near or in contact with the patient during use. CODE a) 6808,...Read More

Company: Consolidated Machine Corp.Product: Steam sterilizers Date: 9/24/03 Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a...Read More