Day

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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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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