Recall Z-2659-2016 ยท LLZ System, Image Processing, Radiological
Novarad Corporation
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 Radi
| Date | Aug 25, 2016 (initiated Aug 12, 2016) |
| Status | Terminated |
| Reason | 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 | 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. Custom |
| Quantity | 90 |
| Distribution | Worldwide Distribution - US (Nationwide) Canada and other foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132853 | NOVAPACS Novarad Corp., Oct 30, 2014 |