Z-1613-2016Class II

NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Name: Z-1613-2016 NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Creator: Novarad Corporation
Published: 2015-11-16
License: https://open.fda.gov/license/

Novarad Corp. / initiated 2015-11-16 / Terminated / root cause: software

FDA source

Novarad Corporation began a recall of NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation on 2015-11-16. FDA classified it as Class II and gives the reason as "The SUV values that are being calculated in the PET/CT fusion tool are incorrect". 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-1613-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-16
Posted: 2016-05-06
Terminated: 2016-08-17
Recalling firm: Novarad Corp.
Product: NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.
Quantity in commerce: 2,386
Distribution: Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
Product codes and lots: Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1613-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-06

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)