Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Recall
- Recall Number
- Z-1885-2019
- Event Number
- 83036
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 17, 2019
- Terminated
- November 20, 2023
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.
The firm issued a medical device correction notice on 05/17/2019. The letter stated the safety issue and provided additional instructions on the use of the system until a service engineer installs the correction. A firm representative will contact the consignee to arrange for the installation.
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50 units