Recall Z-0143-2024— GE Healthcare
Class II · Ongoing
Class II FDA medical device recall by GE Healthcare, initiated 2023-09-08. It names one FDA 510(k) clearance: K211312. Product: Universal Viewer Workflow Manager, Image processing radiological system. Reason: When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer..
- Recalling firm
- GE Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-09-08
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Universal Viewer Workflow Manager, Image processing radiological system
Reason for recall
When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.