[Recalled] Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X — The MR magnet is equipped with 4 lifting blocks, which are positioned on top of… | FDA
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 - Ingenia Ambition X |
|---|---|
| Brand / manufacturer | Philips North America Llc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1795-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 23 April 2021 |
| EAN / barcode | 00884838090040 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in or out by a lifting crane, e.g. during decommissioning or moving activities. A mechanical issue was detected on these hoisting interface blocks on top of the magnet.
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.