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U.S. Department of Health and Human Services

Class 2 Device Recall NovaPACS

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  Class 2 Device Recall NovaPACS see related information
Date Initiated by Firm September 10, 2019
Date Posted September 12, 2020
Recall Status1 Terminated 3 on June 30, 2021
Recall Number Z-2956-2020
Recall Event ID 85347
510(K)Number K171754  
Product Classification System, image processing, radiological - Product Code LLZ
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.
Code Information 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
Recalling Firm/
Manufacturer		 Novarad Corporation
752 E 1180 S Ste 200
American Fork UT 84003-3561
For Additional Information Contact
801-642-1001
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Novarad Corporation
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