FDA Medical Device Recalls (openFDA)
Novarad Corporation: NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
- Recall number
- Z-1613-2016
- Recalling firm
- Novarad Corporation
- Product
- NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
- Status
- Terminated
- Initiated
- 2015-11-16
- Posted
- 2016-05-06
- Terminated
- 2016-08-17
- Reason
- The SUV values that are being calculated in the PET/CT fusion tool are incorrect.
- Root cause
- Software design
- Action
- Consignees were notified on 11/16/15 via letter to contact Novarad Technical Support to arrange for an upgrade to a corrected version of NovaPACS software.
- Quantity
- 2,386
- Distribution
- Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
- Lot, serial or model codes
- Versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4
- 510(k) numbers
- ["K132853"]
- 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