Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012,
FDA device recall Z-1502-2023 · 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
- 153 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 (K082318) | Ge Healthcare Dynamic Imaging Solutions | 2008-08-25 |