Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c)
FDA device recall Z-1501-2023 · posted 2023-05-02 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare
- Reason for recall
- GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- Action taken
- GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.
- Root cause
- Other
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 329 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2023-03-28
- Date posted
- 2023-05-02
- Location
- Chicago, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer (K150420) | GE Healthcare | 2015-05-26 |