March 26, 2014
Company: Siemens Healthcare Diagnostics, Inc.. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/262014 Class lI: PRODUCT Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of...
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Company Medical Information Technology, Inc..Date of Enforcement Report:3/26/2014 Class lI: PRODUCT MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). Recall Number Z-1234-2014 REASON Potential for erroneous result reporting.. RECALLING FIRM/MANUFACTURER Medical Information...
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Company: GE Healthcare LLC Date of Enforcement Report:3/26/2014 Class lI: PRODUCT GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles...
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AAMI TIR50: 2014 “Post-market surveillance of use error management” addresses use error detection for medical devices from the clinical, manufacturer, patient, user, and regulatory perspective. The goal is to provide guidance on how these individuals can best collect, assess, and leverage post-market use error data to mitigate product risk, and to improve product safety and...
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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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