Company:Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE Z-0691-1 through Z-0693-1 Software used on the Computerized Tomography Fluoroscopy CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners REASON: X-ray generation without operator command using unusual program sequence. MANUFACTURER/RECALLING FIRM:...Read More

Company: Toshiba America Medical Systems, Inc.Date of Enforcement Report: 7/18/01 Class: II RECALL NUMBER, PRODUCT AND CODE: Z-0690-1, Impax Technology Inc. DDS Intended use is as Diagnostic Image Display Software Model/catalog number: DS3000, CS5000, XA3000 REASON: Wrong image presents to radiologist upon database query. MANUFACTURER/RECALLING FIRM: Toshiba America Medical Systems, Inc., Tustin, CA RECALL BY:...Read More

Company: SeQual Technologies Inc.Date: 7/18/01 Product: Oxygen Failure to ensure that a process whose results cannot be fully verified by subsequent inspection and testing, has been validated and approved according to established procedures [21 CFR 820.75(a)]. Specifically, your firm has no documented evidence that provides a high degree of assurance that the manufacturing specifications and...Read More