[Recalled] GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premie |
|---|---|
| Brand / manufacturer | GE Healthcare, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0983-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 04 March 2022 |
| EAN / barcode | 00846082115971 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.