Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical imag
FDA device recall Z-1782-2017 · posted 2017-04-11 · Terminated
Recall details
- Recalling firm
- Ge Medical Systems Information T
- 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.
- Action taken
- Firm sent notification letter to all impacted customer accounts. The letter provided the following instructions for customers to follow until the permanent fix for the issue was deployed: 1) The users should be instructed to look at the date on each exam displayed rather than just the labels assigned to the exam by the system. 2) If this problem is detected in your specific workflows, a system administrator can remove the study category labels (Current/Prior/Baseline)from all overlays on the images/exams. A software code change was deployed to customer sites to correct the issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 118
- Distribution
- Nationwide, Worldwide
- Date initiated
- 2013-02-18
- Date posted
- 2017-04-11
- Date terminated
- 2017-07-31
- Location
- Barrington, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CENTRICITY PACS WEB DIAGNOSTIC (K083018) | Ge Healthcare Dynamic Imaging Solutions | 2008-11-14 |