August 12, 2020
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/12/2020 Class II PRODUCT SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Recall Number: Z-2755-2020 REASON Two software issues (1) Using the override function in case of...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 8/12/2020 Class II PRODUCT DCA Vantage Handheld Barcode Scanner – Zebra Model – Model # DS4308 – HC0015BZZWW external accessory to DCA Vantage Analyzer US Recall Number: Z-2747-2020 REASON If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not...
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Company: GE Healthcare, LLC Date of Enforcement Report: 8/12/2020 Class II PRODUCT CARESCAPE ONE, Physiological Patient Monitor – Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. Recall Number: Z-2750-2020 REASON CARESCAPE ONE...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/12/2020 Class I PRODUCT CADD Medfusion Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 Recall Number: Z-2734-2020 REASON Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs. RECALLING FIRM/MANUFACTURER Smiths Medical ASD Inc. on 6/26/2020....
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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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