Recall Z-2300-2016— Ge Healthcare It

Name: FDA recall Z-2300-2016
Creator: U.S. Food and Drug Administration
Published: 2013-02-18

Class II · Terminated

Class II FDA medical device recall by Ge Healthcare It, initiated 2013-02-18, terminated 2017-12-13. It names one FDA 510(k) clearance: K052618. Product: 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: A software defect was discovered that causes images to be out of context with clinical information..

Recalling firm: Ge Healthcare It
Classification: Class II
Status: Terminated
Initiated: 2013-02-18
Terminated: 2017-12-13
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K052618 — IMAGECAST PACSIdx Systems Corp.·cleared 2005-11-17

K-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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.