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.
FDA Recall Z-2300-2016 · Posted None
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Recalling FirmGe Healthcare It
Recall StatusTerminated
Product CodeLLZ
Date Initiated2013-02-18
Date Terminated2017-12-13
Product Quantity13
Reason for Recall
A software defect was discovered that causes images to be out of context with clinical information.
Firm Action
GE sent an "Urgent Medical Device Correction" letter to all affected customers on April 2, 2013.The letter identified the product the problem and the action customers need to take.
The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI #85204.
For further questions, please call ( 847) 277-4468.
Root Cause
Software design
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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