Z-2754-2017 Class II Terminated
FDA device recall Z-2754-2017 was initiated by Merge Healthcare, Inc. on June 13, 2017 and is designated Class II. Reason for recall: When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an i… The recall status is terminated (terminated September 17, 2020). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2017
- Initiation Date
- June 13, 2017
- Termination Date
- September 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
Product Description
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected by appropriate security login which permits only authorized user access. Symphony uses 256 bit or greater encryption via secure socket layer (SSL) to assure a network environment which is secure.
Reason for Recall
When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
Distribution Pattern
FL, IL, CO, MI, CA, NY, ND, OH, CT
Code Information
Version 5.2