Z-2151-2016 Class II Terminated
FDA device recall Z-2151-2016 was initiated by Novarad Corporation on May 9, 2013 and is designated Class II. Reason for recall: Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. The recall status is terminated (terminated December 1, 2016). Affected quantity: 2695.
Recall Details
- Product Type
- Devices
- Report Date
- July 20, 2016
- Initiation Date
- May 9, 2013
- Termination Date
- December 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2695
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.
Distribution Pattern
Worldwide distribution including US nationwide. No Canadian distribution.
Code Information
All NovaPAC software versions 7.4, 7.5, 7.6, and 8.0