April 8, 2015
Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/8/2015 Class lI: PRODUCT Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Recall Number Z-1354-2015 REASON Possibly incomplete archived studies during pre-fetch. In a...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/8/2015 Class lI: PRODUCT Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH Recall Number Z-1359-2015 REASON Philips discovered that a software defect exists in marketed product wherein the...
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Crisis Prevention and Recovery, LLC (CPR) is excited to announce the formation of a new business speciality, HumanFactorsCPR. HumanFactorsCPR is the fourth business speciality under the CPR brand, joining SoftwareCPR, ValidationCPR, and RegulatoryCPR. “One of the most attractive features of our new HumanFactorsCPR services is our capability to bridge the risk analysis process with the...
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Company:Roche Diabetes Care, Inc.Date of Enforcement Report: 4/8/2015 Class lI: PRODUCT ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. Recall Number Z-1369-2015 REASON Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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