Company: Urologix, Inc., Date of Enforcement Report: 1/21/04 Class: II PRODUCT Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from...Read More

Company: Roche Diagnostics Corp.Date of Enforcement Report: 1/21/04 Class: II PRODUCT a) Roche brand OMNI 7 clinical chemistry analyzer; catalog numbers GD0435 and GD0435R. Recall # Z-0326-04; b) Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R. Recall # Z-0327-04; Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and...Read More

Company: Misys Healthcare Systems.Date of Enforcement Report: 1/21/04 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-0235-04. REASON Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by facsimile...Read More

Company: Medtronic MiniMedDate of Enforcement Report: 1/21/04 Class: III PRODUCT Medtronic MiniMed. Model 7311 Solutions Pumps and Meters Software. Recall # Z-0265-04. REASON Accessory software fails to report certain reports following download of data from 712 pump. CODE Version 5.0A. RECALLING FIRM/MANUFACTURER Medtronic MiniMed, Northridge, CA, by visit or FedEx software on CD-rom beginning on...Read More

Company: General Electric Medical Systems Information TechnologyDate of Enforcement Report: 1/21/04 Class: II PRODUCT Solar 9500 Information Monitor. Recall # Z-0250-04. REASON Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first. CODE Software version 3A. RECALLING FIRM/MANUFACTURER General Electric Medical Systems Information Technology, Milwaukee,...Read More