FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2956-2020
- Recalling firm
- Novarad Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-09-10
- Posted
- 2020-09-12
- Terminated
- 2021-06-30
- 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 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K171754"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000117423
- Firm city
- American Fork
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28