Company: Custom Ultrasonics, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Recall Number Z-0426-2014 REASON Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. RECALLING FIRM/MANUFACTURER Custom Ultrasonics, Inc.,...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0374-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:12/4/2013 Class lI: PRODUCT (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system Recall Number Z-0140-2014 REASON A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 12/4/2013 Class lI: PRODUCT ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System) The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger....Read More