FDA Medical Device Recalls (openFDA)
Novarad Corporation: NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
- Recall number
- Z-2151-2016
- Recalling firm
- Novarad Corporation
- Product
- NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
- Status
- Terminated
- Initiated
- 2013-05-09
- Posted
- not on file
- Terminated
- 2016-12-01
- Reason
- Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
- Root cause
- Software design
- Action
- Consignees were notified on 05/09/13 via letter and email to upgrade software and to turn off streaming function.
- Quantity
- 2695
- Distribution
- Worldwide distribution including US nationwide. No Canadian distribution.
- Lot, serial or model codes
- All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0
- 510(k) numbers
- ["K063153"]
- 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