Centricity Universal Viewer Workflow Manager, Image processing radiological system
FDA device recall Z-0142-2024 · posted 2023-10-23 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 85 units
- Distribution
- Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong
- Date initiated
- 2023-09-08
- Date posted
- 2023-10-23
- Location
- Chicago, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K182419) | GE Healthcare | 2018-12-14 |