1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
FDA device recall Z-0860-2022 · posted 2022-04-04 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- There is potential for the images to be flipped left to right.
- Action taken
- This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions and link for customer to access and download the revised service manual.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 653 units
- Distribution
- Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ire
- Date initiated
- 2022-02-18
- Date posted
- 2022-04-04
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT (K121676) | Ge Medical Systems, LLC | 2012-09-20 |
| GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (K052293) | Ge Medical Systems, LLC | 2005-09-21 |