Z-2659-2016Class II

NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and...

Name: Z-2659-2016 NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and...
Creator: Novarad Corporation
Published: 2016-08-12
License: https://open.fda.gov/license/

Novarad Corp. / initiated 2016-08-12 / Terminated / root cause: software

FDA source

Novarad Corporation began a recall of 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... on 2016-08-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2659-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Posted: 2016-08-25
Terminated: 2017-02-22
Recalling firm: Novarad Corp.
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
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Versions 8.4.7, 8.5.3, and 8.5.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2659-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2659-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-25

Product code LLZ

K132853Class IINovapacsNovarad Corp. / cleared 2014-10-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)