Z-1782-2017 Class II Terminated
FDA device recall Z-1782-2017 was initiated by Ge Medical Systems Information T on February 18, 2013 and is designated Class II. Reason for recall: It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manual… The recall status is terminated (terminated July 31, 2017). Affected quantity: 118.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2017
- Initiation Date
- February 18, 2013
- Termination Date
- July 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118
Product Description
Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
Reason for Recall
It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging position appeared incorrectly swapped when the hanging protocol for three comparison studies is manually applied from the patient folder.
Distribution Pattern
Nationwide, Worldwide
Code Information
Versions 1.0, 1.1, 2.0, 2.1