Recall Z-2956-2020 ยท LLZ System, Image Processing, Radiological
Novarad Corporation
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.
| Date | Sep 12, 2020 (initiated Sep 10, 2019) |
| Status | Terminated |
| Reason | 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 | 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 contactin |
| Quantity | 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, Domi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171754 | NovaPACS Novarad Corporation, Jul 28, 2017 |