Company: Novarad Corporation Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation Recall Number Z-1613-2016 REASON IThe SUV values that are being calculated in the PET/CT fusion tool are incorrect. RECALLING FIRM/MANUFACTURER Novarad Corporation, American fork, UT on 11/16/2015. Voluntary: Firm Initiated recall is ongoing....Read More
Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Recall Number Z-1650-2016 REASON It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of...Read More
The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_InvestigationsRead More
Company: Medtronic Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.. Recall Number Z-1648-2016 REASON Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm RECALLING FIRM/MANUFACTURER Medtronic, North Haven, CT on 4/1/2016....Read More
Company: Acusom US Inc. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). Recall Number Z-1638-2016 REASON Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.