Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066
FDA device recall Z-1500-2023 · 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
- 17 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 PACS-IW WITH UNIVERSAL VIEWER (K123174) | GE Healthcare | 2012-11-16 |