Z-2956-2020Class II

NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves...

Name: Z-2956-2020 NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves...
Creator: Novarad Corporation
Published: 2019-09-10
License: https://open.fda.gov/license/

Novarad Corp. / initiated 2019-09-10 / Terminated / root cause: software

FDA source

Novarad Corporation began a recall of NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from... on 2019-09-10. FDA classified it as Class II and gives the reason as "The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be...". 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-2956-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2020-09-12
Terminated: 2021-06-30
Recalling firm: Novarad Corp.
Product: NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display images and data from different modalities including CT, MR, US, CR/DX, NM, PT, and XA.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
Root cause tag: software
FDA root cause: Software Design Change
Action: The firm issued their Urgent Medical Device Correction Notice on 09/24/2019 and letters were sent via certified mail. The issue affected versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8. Customers were instructed to view in the NovaPACS Study Browser's menu what version they are running by selecting "Help" and then selecting "About". The firm informs that the issue has been fixed in versions 8.6.14.62 and 8.7.8.12 and will be in all future releases of the software. It is further explained that you can eliminate the possibility of the malfunction occurring by contacting Technical Support to arrange for an upgrade to a corrected version of the software. This correction is available to all affected customers at no cost and will be included in all future upgrades. Customers will need to FAX, mail, or email the Acknowledgement and Receipt Form back to the firm. For questions or concerns regarding the notification or would like to request an upgrade, you can contact Technical Support at (801) 221-5895.
Quantity in commerce: 197 units
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Canada, Colombia, Dominican Republic, Indonesia, Jordan, Mexico, Peru, Phillipines, and United Kingdom.
Product codes and lots: NovaPACS versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2956-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2956-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-11

Product code LLZ

K171754Class IINovaPACSNovarad Corporation / cleared 2017-07-28

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)