Ge Healthcare It: Medical Device Recall in 2016 - (Recall #: Z-2300-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 18, 2013

Date Posted: August 3, 2016

Recall Number: Z-2300-2016

Event ID: 64758

Reason for Recall:

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

Status: Terminated

Product Quantity: 13

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.

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

N/A