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July 8, 2020
Company: Shanghai United Imaging Healthcare Co., Ltd. Date of Enforcement Report: 7/8/2020 Class II PRODUCT uCT 530 Computed Tomography X-Ray System Recall Number: Z-2472-2020 REASON Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent...
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Recall Number: Z-2471-2020 REASON Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In...
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On June 24, 2020, there was an update to the current status of FDA’s MDDT program. CDRH announced a new tool had qualified as MDDT. This is only the sixth tool to qualify since the MDDT Guidance document was finalized in 2017. See the list of qualified tools here: https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-development-tools-mddt.   What is the Medical...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/8/2020 Class II PRODUCT Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Recall Number: Z-2474-2020 REASON A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 6/2/2020. Voluntary:  Firm...
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Company: Ortho Clinical Diagnostics Date of Enforcement Report: 7/8/2020 Class II PRODUCT VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 Recall Number: Z-2480-2020 REASON Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics on 7/20/2020....
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/8/2020 Class II PRODUCT CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide test ordering...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Overall ISO 14971 risk management
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