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.
Recall
- Recall Number
- Z-2300-2016
- Event Number
- 64758
- Firm
- Ge Healthcare It
- FEI Number
- 3004526608
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- February 18, 2013
- Terminated
- December 13, 2017
- Address
- 540 W Northwest Hwy, Barrington, IL, 60010-3051
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.
A software defect was discovered that causes images to be out of context with clinical information.
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.
US Nationwide Distribution.
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