Z-2300-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- February 18, 2013
- Termination Date
- December 13, 2017
- Voluntary/Mandated
- N/A
- Product Quantity
- 13
Product Description
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging devices and modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by the FDA.
Reason for Recall
A software defect was discovered that causes images to be out of context with clinical information.
Distribution Pattern
US Nationwide Distribution.
Code Information
Imagecast PACS 3.5.69, 3.5.86, 3.5.87 and 3.6 with Centricity. RIS-IC 10.6 versions prior to update Package 18.