Company:Topcon Medical Laser Systems, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient’s eye. Recall Number Z-1774-2013 REASON When using the “Favorites” function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over...Read More

Company:Blood Bank Computer Systems, Inc. Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT Blood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1. Recall Number B-2148-13 REASON Blood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed. RECALLING FIRM/MANUFACTURER Blood Bank Computer Systems, Inc., Auburn, WA on...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/31/2013 Class ll: PRODUCT ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system. Recall Number Z-1782-2013 REASON Siemens issued a customer safety advisory notice and field safety corrective action for...Read More

Company: Del Mar Reynolds Medical, Ltd. Date of Enforcement Report: 7/31/2013 Class lI: PRODUCT Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used...Read More