Recall Z-2151-2016— Novarad Corporation
Class II · Terminated
Class II FDA medical device recall by Novarad Corporation, initiated 2013-05-09, terminated 2016-12-01. It names one FDA 510(k) clearance: K063153. Product: NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS). Reason: Potential for images to be flipped while streaming, which could incorrectly display image orientation markers..
- Recalling firm
- Novarad Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-09
- Terminated
- 2016-12-01
- Firm location
- American Fork, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Reason for recall
Potential for images to be flipped while streaming, which could incorrectly display image orientation markers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.