Day

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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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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