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U.S. Department of Health and Human Services

Class 2 Device Recall NovaPACS

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  Class 2 Device Recall NovaPACS see related information
Date Initiated by Firm August 12, 2016
Date Posted August 25, 2016
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-2659-2016
Recall Event ID 74937
510(K)Number K132853  
Product Classification System, image processing, radiological - Product Code LLZ
Product NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection fraction, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual colonoscopy, and vessel analysis. Images and data are stored on a digital archive with multiple redundancies; images and data are available on-site and offsite. Novarad provides all software, including third party software (i.e. Windows¿ OS). NovaPACS software resides on third party hardware, which may vary depending on the client s PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS is intended for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. NovaPACS is not intended for diagnostic image review on a mobile platform. While NovaPACS provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application
Code Information Versions 8.4.7, 8.5.3, and 8.5.6
Recalling Firm/
Manufacturer		 Novarad Corporation
752 E 1180 S Ste 200
American Fork UT 84003-3561
For Additional Information Contact Doug Merrill
801-642-1001
Manufacturer Reason
for Recall		 Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
FDA Determined
Cause 2		 Software design
Action Novarad sent an Urgent Medical Device Correction letter dated August 12, 2016, to all affected consignees. As a workaround, customers are advised to use the HTMLS Viewer for review purposes only and not for diagnostic purposes. The issue has been fixed in all future releases of NovaPACS software. You can eliminate the possibility of incorrect information appearing by contacting Novarad Technical Supoort to arrange for an upgrade to a corrected version of NovaPACS software. This correction is available to all affected customers at no cost and will be included din all future upgrades. Customers will need to fax, mail, or email th eincluded Acknowledgement and Receipt Form back to Novarad. Customers with questions or concerens regarding this notification or would like to request an upgrade, should contact Novarad Technical Support at 801-221-5895. For questions regarding this recall call 801-642-1001.
Quantity in Commerce 90
Distribution Worldwide Distribution - US (Nationwide) Canada and other foreign consignees.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = NOVARAD CORP.
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