September 16, 2020
Company: SICAT GMBH & CO. KG Date of Enforcement Report: 9/16/2020 Class II PRODUCT SICAT IMPLANT V2.0 Recall Number: Z-2951-2020 REASON A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 – for the specific export format CMG.DXD. RECALLING FIRM/MANUFACTURER SICAT GMBH & CO. KG on 7/15/2020. Voluntary: ...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/16/2020 Class II PRODUCT Merge PACS Recall Number: Z-2944-2020 REASON Measurements done on the Merge PACS generated MPR s may have incorrect measurements. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 8/6/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 125 total units DISTRIBUTION U.S. Nationwide...
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Company: CareFusion 303, Inc. Date of Enforcement Report: 9/16/2020 Class I PRODUCT BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia. Recall Number: Z-2882-2020 REASON The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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