Company: NAGFA Corp.Date of Enforcement Report:6/4/2014 Class lI: PRODUCT IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography. Recall Number Z-1662-2014 REASON Failure to effectively install and test a hotfix to correct the...Read More

Company: GE Healthcare Date of Enforcement Report:6/4/2014 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/42014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1668-2014 REASON Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software version 3.5 (VA35) when using the stress echo feature which could...Read More

Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 6/4/2014 Class lI: PRODUCT ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Recall Number Z-1667-2014 REASON Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) – may incorrectly display the color flow data in the wrong position and when...Read More

Company: Physio-Control, Inc.Date of Enforcement Report:6/42014 Class lI: PRODUCT LIFEPAK 1000 defibrillator. The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest. Recall Number Z-1660-2014 REASON Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to...Read More