SIGNA Artist recall
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Why was SIGNA Artist recalled?
GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient orientation that does not match the patient's actual position may result in incorrectly annotated and/or flipped images.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and identifiers are part of this recall.
- Product
- SIGNA Artist, Nuclear Magnetic Resonance Imaging System
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 562 devices
- Distribution
- Worldwide distributions.
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)