Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 6/04/03 Class: III PRODUCT a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb). Recall # Z-0864-03; b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 6/04/03 Class: III PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Recall # Z-0835-03; b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software. Recall # Z-0836-03; REASON Patient images may be incorrectly stored in the archive directory of a different patient. CODE...Read More