Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management…

Is this the product you have?

• Imagecast PACS with Centricity RIS-IC versions prior to 10.6
• Update Package 18 Product Usageis 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

Lot codes and dates

• 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.

Amount recalled

13

Where it was sold

• Nationwide

Why it was recalled

A software defect was discovered that causes images to be out of context with clinical information.

This product could cause temporary or reversible health problems — stop using it.