Company: Hospira Inc. Date of Enforcement Report 10/26/11 Class ll: PRODUCT 1) Plum A+ Single Channel Infusion Pumps; The pumps were sold under the following configurations: a) list 11971 b) list 11973 – software version 10.3 c) list 12391 – software version 11.3 d) list 20679 – Hospira MedNet Software e) list 20792 – Driver...Read More

Company: Philips Healthcare Inc. Date of Enforcement Report 10/26/11 Class ll: PRODUCT PCR Eleva Radiological Image Processing System with software R.1.2. A computed radiography image processing system. Recall # Z-3205-2011 REASON The mirror icon on the bottom of each image could be interpreted as a RIGHT marker for side indication if the image is mirrored...Read More

IEC Technical Committee 62 established a Software and Network Advisory Group at its meeting in September. Sherman Eagles of SoftwareCPR was named chair of this 7-member international advisory group. The purpose of the group is to advise the TC Chairman and other TC and sub-committee officers on the need for software standards for medical devices,...Read More