July 29, 2020
Company: Medtronic Xomed, Inc. Date of Enforcement Report: 7/29/2020 Class II PRODUCT Software 1898072 IPC upgrade v – Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. Recall Number: Z-2673-2020 REASON During internal testing execution of the next generation...
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Company: Philips North America, LLC Date of Enforcement Report: 7/29/2020 Class II PRODUCT IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 Recall Number: Z-2689-2020 REASON The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and...
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Company: Sysmex America, Inc. Date of Enforcement Report: 7/29/2020 Class II PRODUCT Sysmex PS-10 Sample Preparation System Catalog number: BQ716341 – Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. Recall Number: Z-2687-2020 REASON Insufficient amount of antibody without an error...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/29/2020 Class II PRODUCT Syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 Recall Number: Z-2688-2020 REASON If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different...
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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:

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