Day

July 1, 2020
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/1/2020 Class II PRODUCT RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 Recall Number: Z-2426-2020 REASON It is not obvious that the manual import of a treatment record into RayCare PACS does...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/1/2020 Class II PRODUCT CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro Recall Number: Z-2424-2020 REASON The CARESCAPE Patient Data Module (PDM) is used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro. If Pace detection...
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Company: Siemens Healthcare Diagnostics Inc Date of Enforcement Report: 7/1/2020 Class II PRODUCT RP500e Handheld Barcode Scanner, Zebra Model: DS4308 – HC0062BZZWW, Siemens Material Number (SMN) 11416778 Recall Number: Z-2432-2020 REASON The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics...
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Company: Mevion Medical Systems, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT MEVION S250i, MEVION S250; Proton Radiation Treatment System Recall Number: Z-2406-2020 REASON Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off. RECALLING...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release – Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,...
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Company: Suntech Medical, Inc. Date of Enforcement Report: 7/1/2020 Class II PRODUCT Oscar 2, Model 250 System Recall Number: Z-2429-2020 REASON The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. RECALLING FIRM/MANUFACTURER Suntech Medical, Inc....
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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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