Company: Siemens Medical Solutions USA, Inc..Date of Enforcement Report: 9/22/04 Class: II PRODUCT Axiom Sensis Report Workstation. Recall # Z-1446-04. REASON Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab. CODE Serial Numbers 1002, 1034, 1100-1253, 1300-1504. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA,...Read More

Company:Daavlin Distribution Co.Product:”3 Series Full-body Phototherapy Device” and other phototherapy units Date: 9/22/04 Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR. 820.30(i). For example, design changes made to the 3 Series Full Body Phototherapy...Read More